21 CFR 211.188
Batch production and control records
21 CFR 211.188 is the regulation titled “Batch production and control records” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 76 FDA warning letters have cited it.
- Letters citing it
- 76 since 2021
- Jan 1 to Oct 30, 2026
- 14 against 12 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 59 letters
- Closed out
- 7% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (70 of 76). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.188 most often, as written in the letters.
- 15 lettersYour firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188)
- 5 lettersYour firm failed to prepare batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch…
- 2 lettersFailure to prepare batch production and control records for each batch of drug product produced that include complete information relating to the production and control of each batch, including documentation that each…
The regulation
Read the text of 21 CFR 211.188 (eCFR, as of Sep 1, 2026)
Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch. These records shall include:
(a) An accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed;
(b) Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished, including:
(1) Dates;
(2) Identity of individual major equipment and lines used;
(3) Specific identification of each batch of component or in-process material used;
(4) Weights and measures of components used in the course of processing;
(5) In-process and laboratory control results;
(6) Inspection of the packaging and labeling area before and after use;
(7) A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing;
(8) Complete labeling control records, including specimens or copies of all labeling used;
(9) Description of drug product containers and closures;
(10) Any sampling performed;
(11) Identification of the persons performing and directly supervising or checking each significant step in the operation, or if a significant step in the operation is performed by automated equipment under § 211.68, the identification of the person checking the significant step performed by the automated equipment.
(12) Any investigation made according to § 211.192.
(13) Results of examinations made in accordance with § 211.134.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51933, Sept. 8, 2008]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.188.
- 21 CFR 211.22Responsibilities of quality control unit59 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures55 letters cite both
- 21 CFR 211.100Written procedures; deviations53 letters cite both
- 21 CFR 211.165Testing and release for distribution41 letters cite both
- 21 CFR 211.166Stability testing37 letters cite both
- 21 CFR 211.192Production record review24 letters cite both
- 21 CFR 211.160General requirements21 letters cite both
- 21 CFR 211.67Equipment cleaning and maintenance18 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.188 that FDA posted most recently.
- DrugsView SnugZ USA, Inc.OTC drug products distributed as promotional itemsIssuedSep 28, 2026PostedOct 20, 2026
- DrugsView TCI Co., Ltd BioCosme PABP BRANCHOTC drug products (contract manufacturing)IssuedSep 2, 2026PostedOct 6, 2026
- DrugsView Babikian Healthcare Products CJSCOver-the-counter (OTC) drug productsIssuedSep 21, 2026PostedSep 29, 2026
Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.