21 CFR 211.42(c)(10)(iv) citations
FDA investigators cited 21 CFR 211.42(c)(10)(iv) 452 times at 360 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 | 19 |
| 2025 | 25 |
| 2024 | 34 |
| 2023 | 27 |
| 2022 | 25 |
| 2021 | 18 |
| 2020 | 11 |
| 2019 | 38 |
| 2018 | 27 |
| 2017 | 33 |
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 | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| May 19, 2026 | Samchundang Pharm Co., Ltd. | Korea (the Republic of) | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| May 4, 2026 | Element Materials Technology Boston - Acton Inc. | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| May 1, 2026 | GVS TM, Inc | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Apr 29, 2026 | Samson Pharmaceuticals, Inc | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Apr 24, 2026 | Hanlim Pharm Co. Ltd. | Korea (the Republic of) | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Apr 21, 2026 | Altaire Pharmaceuticals, Inc. | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Apr 14, 2026 | Rohto-Mentholatum (Vietnam) Co., Ltd. | Vietnam | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Mar 12, 2026 | Corixa Corporation | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Feb 27, 2026 | Gallant Pet Inc | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Feb 20, 2026 | Staska Pharmaceuticals, Inc. | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Feb 6, 2026 | Alcami Carolinas Corporation | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Feb 6, 2026 | Eugia Pharma Specialities Limited | India | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Jan 22, 2026 | Excel Vision | France | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Dec 19, 2025 | International Medication Systems Ltd. | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Dec 16, 2025 | Bello Bio LLC | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Dec 11, 2025 | Denver Solutions, LLC | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Nov 12, 2025 | FORDOZ PHARMA CO. | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Nov 5, 2025 | Fresenius Kabi Compounding, LLC | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Sep 26, 2025 | Simtra Deutschland GmbH | Germany | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Sep 19, 2025 | ProRx LLC | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Sep 16, 2025 | Fareva Amboise | France | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Sep 16, 2025 | Lupin Limited | India | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Sep 5, 2025 | Central Admixture Pharmacy Services, Inc. | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
| Aug 28, 2025 | RC Outsourcing, LLC | United States | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. |
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