21 CFR 211.160
General requirements
21 CFR 211.160 is the regulation titled “General requirements” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 140 FDA warning letters have cited it.
- Letters citing it
- 140 since 2021
- Jan 1 to Oct 30, 2026
- 38 against 20 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 72 letters
- Closed out
- 5% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (120 of 140). 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 211.160 most often, as written in the letters.
- 59 lettersYour firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product…
- 4 lettersYour firm failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a))
- 2 lettersYour firm failed to document at the time of performance required laboratory control mechanisms (21 CFR 211.160(a))
The regulation
Read the text of 21 CFR 211.160 (eCFR, as of Sep 1, 2026)
(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. The requirements in this subpart shall be followed and shall be documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms shall be recorded and justified.
(b) Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. Laboratory controls shall include:
(1) Determination of conformity to applicable written specifications for the acceptance of each lot within each shipment of components, drug product containers, closures, and labeling used in the manufacture, processing, packing, or holding of drug products. The specifications shall include a description of the sampling and testing procedures used. Samples shall be representative and adequately identified. Such procedures shall also require appropriate retesting of any component, drug product container, or closure that is subject to deterioration.
(2) Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. Such samples shall be representative and properly identified.
(3) Determination of conformance to written descriptions of sampling procedures and appropriate specifications for drug products. Such samples shall be representative and properly identified.
(4) The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.160.
- 21 CFR 211.22Responsibilities of quality control unit72 letters cite both
- 21 CFR 211.100Written procedures; deviations71 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures64 letters cite both
- 21 CFR 211.192Production record review58 letters cite both
- 21 CFR 211.166Stability testing52 letters cite both
- 21 CFR 211.165Testing and release for distribution37 letters cite both
- 21 CFR 211.113Control of microbiological contamination33 letters cite both
- 21 CFR 211.42Design and construction features28 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.160 that FDA posted most recently.
- DrugsView Pritam International Private LimitedBrush Buddies Cookies 'n Cream Ice Cream Flavored ToothpasteIssuedOct 27, 2026PostedNov 3, 2026
- DrugsView Sanrace Biotechnology Co., Ltd.Over-the-counter (OTC) drug productsIssuedOct 22, 2026PostedOct 27, 2026
- DrugsView TSP Solutions Pte. Ltd.OTC sunscreen drug productsIssuedOct 22, 2026PostedOct 27, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.