21 CFR 211.188 citations
FDA investigators cited 21 CFR 211.188 586 times at 517 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 | 16 |
| 2025 | 21 |
| 2024 | 28 |
| 2023 | 10 |
| 2022 | 21 |
| 2021 | 10 |
| 2020 | 11 |
| 2019 | 35 |
| 2018 | 23 |
| 2017 | 47 |
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 | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Jun 26, 2026 | Hetero Labs Ltd. Unit VI | India | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Jun 19, 2026 | Nowcos Co., Ltd. | Korea (the Republic of) | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Jun 12, 2026 | Safecor Health, LLC | United States | Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch. |
| Jun 5, 2026 | Pillar5 Pharma Inc. | Canada | Batch production and control records do not include complete information relating to the production and control of each batch. |
| May 7, 2026 | Topical Pharmaceuticals, Inc. | United States | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Apr 3, 2026 | Granules Pharmaceuticals Inc. | United States | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Mar 6, 2026 | Pharmaceutics International, Inc. | United States | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Feb 27, 2026 | Tan-Alize Kozmetik Ve Temizlik Urunleri Sanayi Ve Ticaret A.S. | Turkey | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Feb 13, 2026 | K.C. Pharmaceuticals, Inc. | United States | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Feb 5, 2026 | NexCell Scientific Inc | United States | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Dec 19, 2025 | KaryoLogic Inc | United States | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Dec 16, 2025 | Bello Bio LLC | United States | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Nov 28, 2025 | Almac Pharma Services Limited | United Kingdom | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Nov 18, 2025 | Chartwell Pharmaceuticals Congers, LLC | United States | Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch. |
| Oct 8, 2025 | CASAD Company Inc | United States | Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch. |
| Sep 19, 2025 | Thurs Organics Private Limited | India | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Sep 16, 2025 | Fareva Amboise | France | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Aug 28, 2025 | RC Outsourcing, LLC | United States | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Aug 12, 2025 | AQ USA, Inc. | United States | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Jul 30, 2025 | Omega Tech Labs, Inc. | United States | Batch production and control records. |
| Jul 11, 2025 | Reliable Healthcare Logistics | United States | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Jun 20, 2025 | Diagnostic Services Of Kansas State, Inc. | United States | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Jun 13, 2025 | Sun Pharmaceutical Industries Ltd. | India | Batch production and control records do not include complete information relating to the production and control of each batch. |
| Jun 6, 2025 | Pharbil Waltrop Gmbh | Germany | Batch production and control records do not include complete information relating to the production and control of each batch. |
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