21 CFR 211.80(a) citations
FDA investigators cited 21 CFR 211.80(a) 413 times at 364 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Aug 12, 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 | 8 |
| 2025 | 7 |
| 2024 | 7 |
| 2023 | 6 |
| 2022 | 14 |
| 2021 | 6 |
| 2020 | 8 |
| 2019 | 24 |
| 2018 | 22 |
| 2017 | 28 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Aug 12, 2026 | Steril-Gene Life Sciences Private Ltd | India | Written procedures are not followed for the testing of components. |
| Jun 12, 2026 | The Flower Remedy LLC | United States | Written procedures are lacking which describe in sufficient detail the identification, storage, testing, approval and rejection of components, drug product containers and closures. |
| May 1, 2026 | GVS TM, Inc | United States | Written procedures are lacking which describe in sufficient detail the testing of components. |
| Mar 10, 2026 | Cosmetic Lab, Inc. | United States | Written procedures are not followed for the approval of components. |
| Feb 20, 2026 | Aphena Pharma Solutions - Maryland, LLC | United States | Written procedures are lacking which describe in sufficient detail the receipt, testing, approval and rejection of components and drug product containers. |
| Feb 5, 2026 | NexCell Scientific Inc | United States | Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval and rejection of components, drug product containers and closures. |
| Dec 16, 2025 | Bello Bio LLC | United States | Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval and rejection of components and drug product containers. |
| Nov 21, 2025 | B. Braun US Pharmaceutical Manufacturing, LLC | United States | Written procedures are not followed for the approval of components. |
| Sep 29, 2025 | Lexia LLC | United States | Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval and rejection of components, drug product containers and closures. |
| Sep 11, 2025 | Oxygen Development, L.L.C. | United States | Written procedures are lacking which describe in sufficient detail the approval and rejection of components. |
| Aug 22, 2025 | Almac Pharma Services LLC | United States | Written procedures are not followed for the receipt of drug product containers. |
| May 9, 2025 | World Perfumes Inc. | United States | Written procedures are lacking which describe in sufficient detail the testing of components. |
| Mar 20, 2025 | CoreRX Inc. | United States | Written procedures are not followed for the storage of components and drug product containers. |
| Dec 13, 2024 | Vantive Manufacturing Pte. Ltd. | Singapore | Written procedures are not followed for the storage and handling of components. |
| Nov 27, 2024 | Product Society LLC | United States | Written procedures are not followed for the receipt, identification, storage, handling, sampling, testing, approval and rejection of components, drug product containers and closures. |
| Sep 27, 2024 | Haw Par Healthcare Limited | Singapore | Written procedures are not followed for the approval of components. |
| Sep 25, 2024 | Sample Solutions, LLC | United States | Written procedures are not followed for the receipt, identification, storage, handling and approval of components. |
| Sep 6, 2024 | Annovex Pharma, Inc. | United States | Written procedures are lacking which describe in sufficient detail the storage of components, drug product containers and closures. |
| Jul 3, 2024 | MSI Express Inc | United States | Written procedures are lacking which describe in sufficient detail the storage of components. |
| Mar 13, 2024 | Purisys LLC | United States | Written procedures are lacking which describe in sufficient detail the handling of drug product containers. |
| Feb 27, 2024 | Accupack Midwest Inc | United States | Written procedures are lacking which describe in sufficient detail the sampling, testing, approval and rejection of components. |
| Feb 1, 2024 | Centaur Inc | United States | Written procedures are lacking which describe in sufficient detail the sampling of components. |
| Sep 14, 2023 | Select Consumer Group, LLC | United States | Written procedures are lacking which describe in sufficient detail the receipt, storage, handling and approval of components. |
| Jul 21, 2023 | Cosette Pharmaceuticals NC Laboratories, LLC | United States | Written procedures are not followed for the storage and handling of components. |
| Apr 19, 2023 | Playtex Manufacturing Inc | United States | Written procedures are not followed for the receipt and handling of components. |
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