21 CFR 211.194
Laboratory records
21 CFR 211.194 is the regulation titled “Laboratory records” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 46 FDA warning letters have cited it.
- Letters citing it
- 46 since 2021
- Jan 1 to Oct 30, 2026
- 15 against 7 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 31 letters
- Closed out
- 2% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (44 of 46). 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 211.194 most often, as written in the letters.
- 29 lettersYour firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a))
- 1 letterFailure to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards, as required by 21 CFR 211.194(a). For example: i.…
- 1 letterOn multiple occasions, the number of active air monitoring samples documented in environmental monitoring records was not directly traceable to the instrument histories of the specific air samplers identified on those…
The regulation
Read the text of 21 CFR 211.194 (eCFR, as of Sep 1, 2026)
(a) Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows:
(1) A description of the sample received for testing with identification of source (that is, location from where sample was obtained), quantity, lot number or other distinctive code, date sample was taken, and date sample was received for testing.
(2) A statement of each method used in the testing of the sample. The statement shall indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested. (If the method employed is in the current revision of the United States Pharmacopeia, National Formulary, AOAC INTERNATIONAL, Book of Methods, 1 or in other recognized standard references, or is detailed in an approved new drug application and the referenced method is not modified, a statement indicating the method and reference will suffice). The suitability of all testing methods used shall be verified under actual conditions of use.
(3) A statement of the weight or measure of sample used for each test, where appropriate.
(4) A complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, drug product container, closure, in-process material, or drug product, and lot tested.
(5) A record of all calculations performed in connection with the test, including units of measure, conversion factors, and equivalency factors.
(6) A statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the component, drug product container, closure, in-process material, or drug product tested.
(7) The initials or signature of the person who performs each test and the date(s) the tests were performed.
(8) The initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
(b) Complete records shall be maintained of any modification of an established method employed in testing. Such records shall include the reason for the modification and data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method.
(c) Complete records shall be maintained of any testing and standardization of laboratory reference standards, reagents, and standard solutions.
(d) Complete records shall be maintained of the periodic calibration of laboratory instruments, apparatus, gauges, and recording devices required by § 211.160(b)(4).
(e) Complete records shall be maintained of all stability testing performed in accordance with § 211.166.
[43 FR 45077, Sept. 29, 1978, as amended at 55 FR 11577, Mar. 29, 1990; 65 FR 18889, Apr. 10, 2000; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.194.
- 21 CFR 211.22Responsibilities of quality control unit31 letters cite both
- 21 CFR 211.100Written procedures; deviations17 letters cite both
- 21 CFR 211.160General requirements17 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures15 letters cite both
- 21 CFR 211.166Stability testing13 letters cite both
- 21 CFR 211.192Production record review13 letters cite both
- 21 CFR 211.113Control of microbiological contamination12 letters cite both
- 21 CFR 211.165Testing and release for distribution10 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.194 that FDA posted most recently.
- DrugsView Pritam International Private LimitedBrush Buddies Cookies 'n Cream Ice Cream Flavored ToothpasteIssuedOct 27, 2026PostedNov 3, 2026
- DrugsView Rohto Pharmaceutical Co., Ltd.Over-the-counter topical ophthalmic drug products manufactured using aseptic processing.IssuedOct 14, 2026PostedOct 20, 2026
- DrugsView Eurofins SF Analytical Laboratories, Inc.Contract testing laboratory for microbiological analyses of components and drug products.IssuedOct 6, 2026PostedOct 13, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.