21 CFR 211.42(c)(10)(v) citations
FDA investigators cited 21 CFR 211.42(c)(10)(v) 313 times at 259 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jun 5, 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 | 15 |
| 2025 | 14 |
| 2024 | 21 |
| 2023 | 14 |
| 2022 | 20 |
| 2021 | 10 |
| 2020 | 8 |
| 2019 | 27 |
| 2018 | 19 |
| 2017 | 27 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Jun 5, 2026 | Pillar5 Pharma Inc. | Canada | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. |
| Apr 24, 2026 | Hanlim Pharm Co. Ltd. | Korea (the Republic of) | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
| Apr 21, 2026 | Altaire Pharmaceuticals, Inc. | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
| Apr 14, 2026 | Rohto-Mentholatum (Vietnam) Co., Ltd. | Vietnam | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. |
| Mar 6, 2026 | Pharmaceutics International, Inc. | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the to produce aseptic conditions. |
| Mar 5, 2026 | Sharp Sterile Manufacturing, LLC | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions. |
| Feb 27, 2026 | Gallant Pet Inc | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
| Feb 5, 2026 | NexCell Scientific Inc | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
| Jan 22, 2026 | Excel Vision | France | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
| Dec 11, 2025 | Denver Solutions, LLC | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
| Nov 21, 2025 | Sato Pharmaceutical Co., Ltd. | Japan | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
| Nov 12, 2025 | FORDOZ PHARMA CO. | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. |
| Nov 7, 2025 | Alliance Medical Products, Inc. | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions. |
| Nov 5, 2025 | Fresenius Kabi Compounding, LLC | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
| Nov 3, 2025 | Jubilant HollisterStier General Partnership | Canada | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. |
| Sep 26, 2025 | Simtra Deutschland GmbH | Germany | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. |
| Sep 19, 2025 | ProRx LLC | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
| Sep 16, 2025 | Fareva Amboise | France | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. |
| Aug 8, 2025 | OPS International Inc | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the to produce aseptic conditions. |
| Jul 11, 2025 | Sumitomo Dainippon Pharma Co., Ltd. | Japan | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
| Jul 1, 2025 | Shionogi Pharma Co., Ltd. | Japan | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
| Jun 13, 2025 | ALK-Abello, Inc. | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
| May 23, 2025 | Stokes Healthcare Inc. | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. |
| May 15, 2025 | Apothecary Pharma LLC | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
| May 9, 2025 | PCI San Diego, Inc. | United States | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. |
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