21 CFR 211.160: General requirements
Requires laboratory controls with scientifically sound specifications, sampling plans, and test procedures, approved by quality control, documented when performed, with deviations justified, plus lot acceptance testing and calibration of instruments under a written program.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart I, Laboratory Controls
31%
of drug-manufacturing 483s since 2023 cite this section at least once
How FDA words it
The opening lines investigators use most when they cite 211.160, from the 483s we hold.
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality…Most used
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality…211.160(b)
Cited over time
483s citing 211.160, by yearMost citations in 2019. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2019.
Recent 483s citing 211.160
- Right Value Drug Stores LLC · Irving, TexasLaboratory controls do not include the establishment of scientifically sound and… Sep 8, 2026
- RC Outsourcing, LLC · Lowellville, OhioLaboratory controls do not include the establishment of scientifically sound and… Sep 3, 2026
- Tai ls t o rm Hea l th · Chandler, ArizonaLaboratory controls do not include the establishment of scientifically sound and… Aug 28, 2026
- STAQ Pharma of Ohio, LLC · Columbus, OhioLaboratory controls do not include the establishment of scientifically sound and… Aug 19, 2026
- Carolina Infusion, LLC · Ridgeland, South CarolinaInadequate I (6) (4) I on ro) (4) used to sterilize drug products… Aug 18, 2026
The regulation text
§ 211.160 General requirements.
(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]
Questions
What does 21 CFR 211.160 require?
Requires laboratory controls with scientifically sound specifications, sampling plans, and test procedures, approved by quality control, documented when performed, with deviations justified, plus lot acceptance testing and calibration of instruments under a written program.
How often is 211.160 cited in Form 483s?
It appears in about 31% of the drug-manufacturing 483s we hold from 2023 onward, which makes it one of the five most-cited sections in those 483s.
How do FDA investigators word a 211.160 observation?
The most common opening is: “Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality…”
Which sections are cited alongside 211.160?
In the same 483s, investigators most often also cite 211.192 (Production record review), 211.22 (Responsibilities of quality control unit), 211.67 (Equipment cleaning and maintenance), 211.113 (Control of microbiological contamination).