21 CFR 211.194(a) citations
FDA investigators cited 21 CFR 211.194(a) 330 times at 291 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 | 11 |
| 2025 | 14 |
| 2024 | 18 |
| 2023 | 12 |
| 2022 | 8 |
| 2021 | 11 |
| 2020 | 11 |
| 2019 | 25 |
| 2018 | 26 |
| 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 | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Aug 3, 2026 | Bushu Pharmaceuticals Ltd. | Japan | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| May 29, 2026 | Pace Analytical Life Sciences, LLC | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| May 15, 2026 | Canyon Rush, LLC | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Apr 22, 2026 | Alcami Carolinas Corporation | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Apr 14, 2026 | Rohto-Mentholatum (Vietnam) Co., Ltd. | Vietnam | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Jan 23, 2026 | Benuvia Operations, LLC | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Jan 16, 2026 | PTI Georgia, LLC | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. Electronic records are used, but they do not… |
| Dec 19, 2025 | Laboratorios Jaloma S.A. De C.V. | Mexico | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Nov 3, 2025 | Beauty Manufacturing Solutions Corp. | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Oct 29, 2025 | Dendreon Pharmaceuticals LLC | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Sep 16, 2025 | Microbiological Testing & Consulting, LLC | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Sep 4, 2025 | Sparsha Pharma Usa Inc | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Aug 8, 2025 | AnazaoHealth Corporation | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Aug 8, 2025 | Derma Care Research Labs LLC | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Jul 18, 2025 | Daiichi Sankyo Europe GmbH | Germany | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Jul 11, 2025 | Sun Deep Inc. | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Jul 8, 2025 | Delta Labs Of South Florida Corp | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Mar 21, 2025 | Aprecia Pharmaceuticals, LLC | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Feb 6, 2025 | Pharmaplast S.A.E. | Egypt | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Jan 23, 2025 | A.P. Deauville, LLC | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Jan 21, 2025 | Resilience US, LLC | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Dec 16, 2024 | GMP Laboratories Of America Inc | United States | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Dec 3, 2024 | Vantive Manufacturing (Thailand) Company | Thailand | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
| Nov 29, 2024 | Kovas Co., Ltd. | Korea (the Republic of) | Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. |
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