21 CFR 211.100(b) citations
FDA investigators cited 21 CFR 211.100(b) 883 times at 714 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 23, 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 | 21 |
| 2025 | 32 |
| 2024 | 16 |
| 2023 | 29 |
| 2022 | 31 |
| 2021 | 20 |
| 2020 | 15 |
| 2019 | 36 |
| 2018 | 46 |
| 2017 | 50 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Sep 23, 2026 | Baxter Healthcare Corporation | United States | Written production and process control procedures are not followed in the execution of production and process control functions. |
| Aug 12, 2026 | Steril-Gene Life Sciences Private Ltd | India | Written production and process control procedures are not documented at the time of performance. |
| May 18, 2026 | Viatris Pharmaceuticals LLC | United States | Written production and process control procedures are not followed in the execution of production and process control functions. |
| May 15, 2026 | Sciegen Pharmaceuticals Inc | United States | Written production and process control procedures are not followed in the execution of production and process control functions. |
| May 1, 2026 | GVS TM, Inc | United States | Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. |
| Apr 28, 2026 | Micro Measurement Laboratories, Inc. | United States | Written production and process control procedures are not followed in the execution of production and process control functions. |
| Apr 21, 2026 | Ajanta Pharma Ltd. | India | Written production and process control procedures are not followed in the execution of production and process control functions. |
| Apr 20, 2026 | New SPS Crossfolds, LLC | United States | Deviations from written production and process control procedures are not recorded and justified. |
| Apr 7, 2026 | Catalent Massachusetts, LLC | United States | Written production and process control procedures are not followed in the execution of production and process control functions. |
| Apr 2, 2026 | Baxter Healthcare Corporation | United States | Deviations from written production and process control procedures are not recorded. |
| Mar 23, 2026 | Dr. J Skinclinic, Inc | United States | Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. |
| Feb 27, 2026 | Tan-Alize Kozmetik Ve Temizlik Urunleri Sanayi Ve Ticaret A.S. | Turkey | Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. |
| Feb 10, 2026 | Kenvue Brands LLC | United States | Written production and process control procedures are not followed in the execution of production and process control functions. |
| Feb 5, 2026 | Fenwal International, Inc. | United States | Written production and process control procedures are not followed in the execution of production and process control functions. |
| Feb 5, 2026 | Grifols Therapeutics LLC | United States | Written production and process control procedures are not followed in the execution of production and process control functions. |
| Feb 5, 2026 | ONY Biotech, Inc. | United States | Deviations from written production and process control procedures are not recorded and justified. |
| Dec 11, 2025 | Bloodworks | United States | Written production and process control procedures are not followed in the execution of production and process control functions. |
| Oct 31, 2025 | RNV LLC | United States | Written production and process control procedures are not documented at the time of performance. |
| Oct 31, 2025 | Weckerle Cosmetics USA, INC | United States | Deviations from written production and process control procedures are not. |
| Oct 24, 2025 | Frontida Biopharm, LLC | United States | Written production and process control procedures are not followed in the execution of production and process control functions. |
| Oct 3, 2025 | Aucta Pharmaceuticals, Inc. | United States | Written production and process control procedures are not followed in the execution of production and process control functions. |
| Sep 30, 2025 | Indiana Botanic Gardens, Inc | United States | Written production and process control procedures are not followed in the execution of production and process control functions. |
| Sep 26, 2025 | Alcami Carolinas Corporation | United States | Written production and process control procedures are not followed in the execution of production and process control functions. |
| Sep 12, 2025 | Nippon Shikizai, Inc. | Japan | Deviations from written production and process control procedures are not justified. |
| Aug 27, 2025 | Melaleuca Inc | United States | Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. |
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