21 CFR 211.160(b) citations
FDA investigators cited 21 CFR 211.160(b) 1,449 times at 1,119 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Aug 14, 2026. A citation is an observation listed on Form FDA 483 at the end of an inspection; it is not a final agency decision.
Citations by fiscal year
| FDA fiscal year | Citations |
|---|---|
| 2026 | 73 |
| 2025 | 112 |
| 2024 | 98 |
| 2023 | 63 |
| 2022 | 68 |
| 2021 | 38 |
| 2020 | 42 |
| 2019 | 105 |
| 2018 | 97 |
| 2017 | 98 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Aug 14, 2026 | AptaPharma Inc. | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. |
| Aug 12, 2026 | Steril-Gene Life Sciences Private Ltd | India | Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength… |
| Jul 23, 2026 | Fuller Industries Inc | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components, in-process materials and drug products… |
| Jul 20, 2026 | Biochemical And Scientific Consultants Cc | South Africa | 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… |
| Jul 14, 2026 | Aspen SA Sterile Operations (Pty) Ltd. | South Africa | Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components, drug product containers, closures, in-process materials… |
| Jul 10, 2026 | Playtex Manufacturing Inc | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components and drug products conform to appropriate… |
| Jul 9, 2026 | Lexamed, Ltd | United States | 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… |
| Jun 30, 2026 | Meridian Medical Technologies, LLC A Subsidiary Of Kindeva Drug Delivery, L.P. | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that in-process materials and drug products conform to appropriate… |
| Jun 26, 2026 | Advanced Cosmetic Research Laboratories, Inc. | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components and drug products conform to… |
| Jun 26, 2026 | Biokosmes Srl | Italy | 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… |
| Jun 26, 2026 | Natural Essentials Incorporated | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that components conform to appropriate standards of identity, strength, quality and purity. |
| Jun 26, 2026 | S.S.S. Company (International) | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that drug products conform to appropriate… |
| Jun 23, 2026 | Scinopharm Taiwan, Ltd. | Taiwan | 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… |
| Jun 12, 2026 | Product Society LLC | United States | 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… |
| Jun 9, 2026 | SGS North America Inc. | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers… |
| Jun 3, 2026 | Eurofins SF Analytical Laboratories, Inc. | United States | 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… |
| May 20, 2026 | Belmar Labs, LLC | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that conform to appropriate standards of identity, strength, quality and purity. |
| May 15, 2026 | Canyon Rush, LLC | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that components conform to appropriate standards of identity, strength, quality and purity. |
| May 15, 2026 | Emcure Pharmaceuticals Limited | India | 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… |
| May 15, 2026 | Unither Manufacturing LLC. | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that in-process materials conform to appropriate standards of identity… |
| May 8, 2026 | PPL Healthcare LLC | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components and drug products conform to appropriate standards of… |
| May 7, 2026 | Topical Pharmaceuticals, Inc. | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to… |
| May 1, 2026 | SnugZ USA, Inc. | United States | Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components, in-process materials and drug products… |
| Apr 30, 2026 | Microchem Laboratory | United States | 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… |
| Apr 24, 2026 | Hanlim Pharm Co. Ltd. | Korea (the Republic of) | 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… |
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