# Evidence packet — 21 CFR Part 211

Generated 2026-09-18. Packet version 1.
Published at https://gxplex.com/packet/us-21-cfr-part-211

This packet reports what a publisher published and when this record observed it. It carries no assessment of what the document requires and no reading of what any change means.

## Source

| field | value |
| --- | --- |
| id | us-21-cfr-part-211 |
| title | 21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals |
| jurisdiction | US |
| source url (asked) | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| answered url | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| observed cadence | weekly |
| row | https://gxplex.com/r/us-21-cfr-part-211 |

## Publisher

| field | value |
| --- | --- |
| authority | US Food and Drug Administration |
| origin host | — |
| origin citation | — |
| standards body | — |
| standards body citation | — |

No origin host is recorded for this row. The authority named above is the body; the host is a fact about which origin answered, and this row does not carry one.

## Type

| field | value |
| --- | --- |
| class as stated by the publisher | legal act |
| read from | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| source kind, recorded here | document |
| source type, recorded here | document |
| record tier | core |

## Lifecycle

| field | value |
| --- | --- |
| status | in-force |
| status qualifier | — |
| status as of | — |
| effective date | — |
| last changed | — |
| status read from | — |
| status withdrawn | — |
| status withdrawn on | — |
| decay class | live |
| frozen reason | — |

These are the dates the record holds for this document's own status. They state nothing about which products or activities the document reaches.

## Verification

| field | value |
| --- | --- |
| state | ● verified |
| what the state states | checked against the primary source by a person |
| checked by | human |
| check date | — |
| last verified | 2026-08-01 |

## Terms

| field | value |
| --- | --- |
| licence class | open |
| text retained here | yes |
| quotation appears in this record | yes |
| snapshot retained here | yes |

## Observations with retained text

| first seen | seq | days | digest | class | answered at | bytes |
| --- | --- | --- | --- | --- | --- | --- |
| 2026-07-31 | 1 | 8 | 393b48f902b837662950a1aec5bca642ec0dc2b1487d5dec104ccd6373b451fa | document | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 | 88643 |
| 2026-08-08 | 1 | 6 | 5997ebbb66615f64b6eeee4e643bbae371cfa262fa2aae4b19645508b3189561 | document | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 | 88643 |
| 2026-08-14 | 1 | 4 | 9d7b6d9aa4e134c40e14f458fc10130b2c105e71fd482694c63a306dc77f1d43 | document | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 | 88643 |
| 2026-08-19 | 1 | 2 | 18e04a0c925a01486357077898c82ba38eb236f8f4423a2071952465e827a0d8 | document | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 | 88643 |
| 2026-08-21 | 1 | 7 | 1e7f136841292df1484cbe2668c3f941f7005a63539be671db5cdb831bd57a59 | document | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 | 88643 |
| 2026-08-28 | 1 | 1 | f24b92ecdf425f86f463835a80a86142c45308ee43cdba5c7d6f64d4845bf23d | document | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 | 88643 |
| 2026-08-29 | 1 | 2 | b670ac9656b7eed06935ddab3e5382672dccf4d4f2f00bfa9c04815bd83c606d | document | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 | 88643 |
| 2026-08-31 | 1 | 2 | bc527e48bcd825107e370b161505f7b4b261a1fdfe8cd71be2cedd70b1572971 | document | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 | 88711 |
| 2026-09-02 | 1 | 6 | 4edb9480421c24ce478d141081e716451837cc2dcdb0771da63b85912af7e0eb | document | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 | 88711 |
| 2026-09-08 | 1 | 11 | cd3e1c0c936b59ded15e4c38e27a38b03e2e1d8b6a00fd2c82629696dd6a103c | document | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 | 87662 |

Digests recorded: 10. With retained text: 10. Without: 0. Series state: comparable.

## Changes

One entry per consecutive pair of retained readings, in the order this record first saw each digest. Every entry carries a measured difference or the first condition that refused one. A refused entry was never tested against the conditions after it.

| from | to | verdict | condition | words | exact |
| --- | --- | --- | --- | --- | --- |
| 2026-07-31#1 | 2026-08-08#1 | difference | — | 2 | yes |
| 2026-08-08#1 | 2026-08-14#1 | difference | — | 2 | yes |
| 2026-08-14#1 | 2026-08-19#1 | difference | — | 2 | yes |
| 2026-08-19#1 | 2026-08-21#1 | difference | — | 2 | yes |
| 2026-08-21#1 | 2026-08-28#1 | difference | — | 2 | yes |
| 2026-08-28#1 | 2026-08-29#1 | difference | — | 2 | yes |
| 2026-08-29#1 | 2026-08-31#1 | difference | — | 8 | yes |
| 2026-08-31#1 | 2026-09-02#1 | difference | — | 2 | yes |
| 2026-09-02#1 | 2026-09-08#1 | withheld | over-ceiling | 90 | no |

### 2026-07-31#1 → 2026-08-08#1

| field | value |
| --- | --- |
| earlier digest | 393b48f902b837662950a1aec5bca642ec0dc2b1487d5dec104ccd6373b451fa |
| later digest | 5997ebbb66615f64b6eeee4e643bbae371cfa262fa2aae4b19645508b3189561 |
| earlier answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| later answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 2 |
| figure is exact | yes |
| words removed | 1 |
| words added | 1 |
| the words that differ, published at | https://gxplex.com/compare/us-21-cfr-part-211#cmp-2026-07-31-1-2026-08-08-1 |

### 2026-08-08#1 → 2026-08-14#1

| field | value |
| --- | --- |
| earlier digest | 5997ebbb66615f64b6eeee4e643bbae371cfa262fa2aae4b19645508b3189561 |
| later digest | 9d7b6d9aa4e134c40e14f458fc10130b2c105e71fd482694c63a306dc77f1d43 |
| earlier answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| later answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 2 |
| figure is exact | yes |
| words removed | 1 |
| words added | 1 |
| the words that differ, published at | https://gxplex.com/compare/us-21-cfr-part-211#cmp-2026-08-08-1-2026-08-14-1 |

### 2026-08-14#1 → 2026-08-19#1

| field | value |
| --- | --- |
| earlier digest | 9d7b6d9aa4e134c40e14f458fc10130b2c105e71fd482694c63a306dc77f1d43 |
| later digest | 18e04a0c925a01486357077898c82ba38eb236f8f4423a2071952465e827a0d8 |
| earlier answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| later answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 2 |
| figure is exact | yes |
| words removed | 1 |
| words added | 1 |
| the words that differ, published at | https://gxplex.com/compare/us-21-cfr-part-211#cmp-2026-08-14-1-2026-08-19-1 |

### 2026-08-19#1 → 2026-08-21#1

| field | value |
| --- | --- |
| earlier digest | 18e04a0c925a01486357077898c82ba38eb236f8f4423a2071952465e827a0d8 |
| later digest | 1e7f136841292df1484cbe2668c3f941f7005a63539be671db5cdb831bd57a59 |
| earlier answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| later answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 2 |
| figure is exact | yes |
| words removed | 1 |
| words added | 1 |
| the words that differ, published at | https://gxplex.com/compare/us-21-cfr-part-211#cmp-2026-08-19-1-2026-08-21-1 |

### 2026-08-21#1 → 2026-08-28#1

| field | value |
| --- | --- |
| earlier digest | 1e7f136841292df1484cbe2668c3f941f7005a63539be671db5cdb831bd57a59 |
| later digest | f24b92ecdf425f86f463835a80a86142c45308ee43cdba5c7d6f64d4845bf23d |
| earlier answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| later answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 2 |
| figure is exact | yes |
| words removed | 1 |
| words added | 1 |
| the words that differ, published at | https://gxplex.com/compare/us-21-cfr-part-211#cmp-2026-08-21-1-2026-08-28-1 |

### 2026-08-28#1 → 2026-08-29#1

| field | value |
| --- | --- |
| earlier digest | f24b92ecdf425f86f463835a80a86142c45308ee43cdba5c7d6f64d4845bf23d |
| later digest | b670ac9656b7eed06935ddab3e5382672dccf4d4f2f00bfa9c04815bd83c606d |
| earlier answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| later answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 2 |
| figure is exact | yes |
| words removed | 1 |
| words added | 1 |
| the words that differ, published at | https://gxplex.com/compare/us-21-cfr-part-211#cmp-2026-08-28-1-2026-08-29-1 |

### 2026-08-29#1 → 2026-08-31#1

| field | value |
| --- | --- |
| earlier digest | b670ac9656b7eed06935ddab3e5382672dccf4d4f2f00bfa9c04815bd83c606d |
| later digest | bc527e48bcd825107e370b161505f7b4b261a1fdfe8cd71be2cedd70b1572971 |
| earlier answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| later answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 8 |
| figure is exact | yes |
| words removed | 1 |
| words added | 7 |
| the words that differ, published at | https://gxplex.com/compare/us-21-cfr-part-211#cmp-2026-08-29-1-2026-08-31-1 |

### 2026-08-31#1 → 2026-09-02#1

| field | value |
| --- | --- |
| earlier digest | bc527e48bcd825107e370b161505f7b4b261a1fdfe8cd71be2cedd70b1572971 |
| later digest | 4edb9480421c24ce478d141081e716451837cc2dcdb0771da63b85912af7e0eb |
| earlier answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| later answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| verdict | difference |
| condition | — |
| condition kind | — |
| words differing | 2 |
| figure is exact | yes |
| words removed | 1 |
| words added | 1 |
| the words that differ, published at | https://gxplex.com/compare/us-21-cfr-part-211#cmp-2026-08-31-1-2026-09-02-1 |

### 2026-09-02#1 → 2026-09-08#1

A faithful difference is longer than the word ceiling this site publishes under. It is withheld whole rather than cut to fit: a shortened quote is a fabricated measurement of what a publisher wrote. The figures below are counts of the difference, not the difference.

| field | value |
| --- | --- |
| earlier digest | 4edb9480421c24ce478d141081e716451837cc2dcdb0771da63b85912af7e0eb |
| later digest | cd3e1c0c936b59ded15e4c38e27a38b03e2e1d8b6a00fd2c82629696dd6a103c |
| earlier answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| later answered at | https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 |
| verdict | withheld |
| condition | over-ceiling |
| condition kind | refused |
| words differing | 90 |
| figure is exact | no |
| words removed | — |
| words added | — |
| the comparison entry, which publishes no words for this pair | https://gxplex.com/compare/us-21-cfr-part-211#cmp-2026-09-02-1-2026-09-08-1 |


## Integrity

| field | value |
| --- | --- |
| root | fd0980cf7ca42518ff7457b92b075df16163772d48d6f75e546b4869fe7bedab |
| leaves the root covers | 5393 |
| algorithm | SHA-256 over sorted `id\|date\|content_hash` lines, pairwise; an odd final node is promoted, never doubled. |
| fixed on | 2026-09-18 |
| root published at | https://gxplex.com/integrity/root.txt |
| leaves published at | https://gxplex.com/integrity/leaves.txt |
| the commands | https://gxplex.com/verify |
| leaf lines for this row | 49 |

The root is over every leaf line the record holds, not over the lines below. Reducing it needs the published file, which is served whole at the address named here together with the command that reduces it. These lines are this row's own slice of that file, copied verbatim.

```
us-21-cfr-part-211|2026-07-31|393b48f902b837662950a1aec5bca642ec0dc2b1487d5dec104ccd6373b451fa
us-21-cfr-part-211|2026-08-01|393b48f902b837662950a1aec5bca642ec0dc2b1487d5dec104ccd6373b451fa
us-21-cfr-part-211|2026-08-02|393b48f902b837662950a1aec5bca642ec0dc2b1487d5dec104ccd6373b451fa
us-21-cfr-part-211|2026-08-03|393b48f902b837662950a1aec5bca642ec0dc2b1487d5dec104ccd6373b451fa
us-21-cfr-part-211|2026-08-04|393b48f902b837662950a1aec5bca642ec0dc2b1487d5dec104ccd6373b451fa
us-21-cfr-part-211|2026-08-05|393b48f902b837662950a1aec5bca642ec0dc2b1487d5dec104ccd6373b451fa
us-21-cfr-part-211|2026-08-06|393b48f902b837662950a1aec5bca642ec0dc2b1487d5dec104ccd6373b451fa
us-21-cfr-part-211|2026-08-07|393b48f902b837662950a1aec5bca642ec0dc2b1487d5dec104ccd6373b451fa
us-21-cfr-part-211|2026-08-08|5997ebbb66615f64b6eeee4e643bbae371cfa262fa2aae4b19645508b3189561
us-21-cfr-part-211|2026-08-09|5997ebbb66615f64b6eeee4e643bbae371cfa262fa2aae4b19645508b3189561
us-21-cfr-part-211|2026-08-10|5997ebbb66615f64b6eeee4e643bbae371cfa262fa2aae4b19645508b3189561
us-21-cfr-part-211|2026-08-11|5997ebbb66615f64b6eeee4e643bbae371cfa262fa2aae4b19645508b3189561
us-21-cfr-part-211|2026-08-12|5997ebbb66615f64b6eeee4e643bbae371cfa262fa2aae4b19645508b3189561
us-21-cfr-part-211|2026-08-13|5997ebbb66615f64b6eeee4e643bbae371cfa262fa2aae4b19645508b3189561
us-21-cfr-part-211|2026-08-14|9d7b6d9aa4e134c40e14f458fc10130b2c105e71fd482694c63a306dc77f1d43
us-21-cfr-part-211|2026-08-15|9d7b6d9aa4e134c40e14f458fc10130b2c105e71fd482694c63a306dc77f1d43
us-21-cfr-part-211|2026-08-16|9d7b6d9aa4e134c40e14f458fc10130b2c105e71fd482694c63a306dc77f1d43
us-21-cfr-part-211|2026-08-18|9d7b6d9aa4e134c40e14f458fc10130b2c105e71fd482694c63a306dc77f1d43
us-21-cfr-part-211|2026-08-19|18e04a0c925a01486357077898c82ba38eb236f8f4423a2071952465e827a0d8
us-21-cfr-part-211|2026-08-20|18e04a0c925a01486357077898c82ba38eb236f8f4423a2071952465e827a0d8
us-21-cfr-part-211|2026-08-21|1e7f136841292df1484cbe2668c3f941f7005a63539be671db5cdb831bd57a59
us-21-cfr-part-211|2026-08-22|1e7f136841292df1484cbe2668c3f941f7005a63539be671db5cdb831bd57a59
us-21-cfr-part-211|2026-08-23|1e7f136841292df1484cbe2668c3f941f7005a63539be671db5cdb831bd57a59
us-21-cfr-part-211|2026-08-24|1e7f136841292df1484cbe2668c3f941f7005a63539be671db5cdb831bd57a59
us-21-cfr-part-211|2026-08-25|1e7f136841292df1484cbe2668c3f941f7005a63539be671db5cdb831bd57a59
us-21-cfr-part-211|2026-08-26|1e7f136841292df1484cbe2668c3f941f7005a63539be671db5cdb831bd57a59
us-21-cfr-part-211|2026-08-27|1e7f136841292df1484cbe2668c3f941f7005a63539be671db5cdb831bd57a59
us-21-cfr-part-211|2026-08-28|f24b92ecdf425f86f463835a80a86142c45308ee43cdba5c7d6f64d4845bf23d
us-21-cfr-part-211|2026-08-29|b670ac9656b7eed06935ddab3e5382672dccf4d4f2f00bfa9c04815bd83c606d
us-21-cfr-part-211|2026-08-30|b670ac9656b7eed06935ddab3e5382672dccf4d4f2f00bfa9c04815bd83c606d
us-21-cfr-part-211|2026-08-31|bc527e48bcd825107e370b161505f7b4b261a1fdfe8cd71be2cedd70b1572971
us-21-cfr-part-211|2026-09-01|bc527e48bcd825107e370b161505f7b4b261a1fdfe8cd71be2cedd70b1572971
us-21-cfr-part-211|2026-09-02|4edb9480421c24ce478d141081e716451837cc2dcdb0771da63b85912af7e0eb
us-21-cfr-part-211|2026-09-03|4edb9480421c24ce478d141081e716451837cc2dcdb0771da63b85912af7e0eb
us-21-cfr-part-211|2026-09-04|4edb9480421c24ce478d141081e716451837cc2dcdb0771da63b85912af7e0eb
us-21-cfr-part-211|2026-09-05|4edb9480421c24ce478d141081e716451837cc2dcdb0771da63b85912af7e0eb
us-21-cfr-part-211|2026-09-06|4edb9480421c24ce478d141081e716451837cc2dcdb0771da63b85912af7e0eb
us-21-cfr-part-211|2026-09-07|4edb9480421c24ce478d141081e716451837cc2dcdb0771da63b85912af7e0eb
us-21-cfr-part-211|2026-09-08|cd3e1c0c936b59ded15e4c38e27a38b03e2e1d8b6a00fd2c82629696dd6a103c
us-21-cfr-part-211|2026-09-09|cd3e1c0c936b59ded15e4c38e27a38b03e2e1d8b6a00fd2c82629696dd6a103c
us-21-cfr-part-211|2026-09-10|cd3e1c0c936b59ded15e4c38e27a38b03e2e1d8b6a00fd2c82629696dd6a103c
us-21-cfr-part-211|2026-09-11|cd3e1c0c936b59ded15e4c38e27a38b03e2e1d8b6a00fd2c82629696dd6a103c
us-21-cfr-part-211|2026-09-12|cd3e1c0c936b59ded15e4c38e27a38b03e2e1d8b6a00fd2c82629696dd6a103c
us-21-cfr-part-211|2026-09-13|cd3e1c0c936b59ded15e4c38e27a38b03e2e1d8b6a00fd2c82629696dd6a103c
us-21-cfr-part-211|2026-09-14|cd3e1c0c936b59ded15e4c38e27a38b03e2e1d8b6a00fd2c82629696dd6a103c
us-21-cfr-part-211|2026-09-15|cd3e1c0c936b59ded15e4c38e27a38b03e2e1d8b6a00fd2c82629696dd6a103c
us-21-cfr-part-211|2026-09-16|cd3e1c0c936b59ded15e4c38e27a38b03e2e1d8b6a00fd2c82629696dd6a103c
us-21-cfr-part-211|2026-09-17|cd3e1c0c936b59ded15e4c38e27a38b03e2e1d8b6a00fd2c82629696dd6a103c
us-21-cfr-part-211|2026-09-18|cd3e1c0c936b59ded15e4c38e27a38b03e2e1d8b6a00fd2c82629696dd6a103c
```

## What this packet does not carry

- **the words that differ** — A count of a difference is in this packet; the words are not. They are a publisher's text, and this record checks borrowed text only on the surfaces it enumerates — a packet carrying spans under a key those checks do not read would be borrowed text nothing verifies. Each change names the comparison entry for the same pair, and says which of the two is at that address: the words, where a difference was measured and is inside the word ceiling; otherwise the same condition this entry names, with no text of the document.
- **this records own prose** — The row's summary and its account of an unresolved address are this archive's own voice. They are leads and not evidence, however accurate, because a faithful paraphrase is indistinguishable from evidence while remaining ours. They are published on the row's page and are not here.
- **any field that would characterise a change** — No score, no rank, no ordering by judgment, no reading of what a change means and no word for how much of it counts. A packet is evidence taken elsewhere, and a field characterising it would be an opinion with digests attached.
- **a recomputed root** — The integrity block states the root this record published and the leaf lines for this row. It computes no root of its own: two numbers this record produced, compared with each other, check nothing.

## The conditions, in the order they are evaluated

Counted over the 9 transition(s) above.

| condition | changes | what it states |
| --- | --- | --- |
| licence-restricted | none | No text from this document appears on this site, so no difference between two readings of it is shown either. The digests, the dates and the addresses are the record for this row. |
| licence-unread | none | No reading of the terms this source states is recorded for the row. That is an absent reading rather than an absent term, and the row is handled here exactly as a restricted one until a reading is recorded. |
| date-not-observed | not reached | No observation of this row on that day holds retained text. |
| date-not-unique | not reached | That day holds more than one distinct retained digest for this row, so a date alone does not name one observation. The addressed form — the day and the sequence within it — does. |
| one-point | not reached | Both dates resolve to the same observation. |
| referent-unclassified | none | The class of one of these observations could not be read, so neither was shown to be an observation of the document itself. |
| referent-class | none | One of these observations is not of the document. A listing page that names the document and the document are different subjects, and a difference between them is not a difference in the document. |
| referent-normalisation | none | These two digests were taken over different kinds of text — one over markup, one over prose extracted from a file — so the words they yield differ for a reason that is not the publisher’s. |
| referent-address | none | These two observations answered at different addresses. A difference between them is at least in part a difference between two pages. |
| text-not-retained | none | No normalised text is held here for one of these observations, so there is nothing on this side to compare. |
| snapshot-unreadable | none | Normalised text is recorded for one of these observations and could not be read from this record. |
| span-unverified | none | A span this comparison would have shown could not be found, word for word and in that order, in the retained text it was drawn from. The comparison is withheld rather than shown: a phrase assembled out of words a publisher did not write next to each other is a fabricated measurement of what the publisher wrote. |
| over-ceiling | 1 | A faithful difference is longer than the word ceiling this site publishes under. It is withheld whole rather than cut to fit: a shortened quote is a fabricated measurement of what a publisher wrote. The figures below are counts of the difference, not the difference. |

Three of the conditions belong to the form of the comparison that resolves two dates. Every comparison in this packet is formed from readings addressed by the key the store gives them, so those three are never evaluated here: their absence from the entries above records that they were not tested, rather than that they were tested and did not fire.

Word ceiling: 14.