21 CFR 211.110(a) citations
FDA investigators cited 21 CFR 211.110(a) 936 times at 711 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 | 20 |
| 2025 | 45 |
| 2024 | 30 |
| 2023 | 35 |
| 2022 | 30 |
| 2021 | 20 |
| 2020 | 28 |
| 2019 | 58 |
| 2018 | 67 |
| 2017 | 56 |
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 | Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. |
| Aug 3, 2026 | Bushu Pharmaceuticals Ltd. | Japan | Written procedures are not established that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch. |
| Jun 30, 2026 | Meridian Medical Technologies, LLC A Subsidiary Of Kindeva Drug Delivery, L.P. | United States | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| Jun 26, 2026 | Hetero Labs Ltd. Unit VI | India | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| May 1, 2026 | GVS TM, Inc | United States | Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch. |
| Mar 20, 2026 | Teva Womens Health, LLC | United States | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| Mar 10, 2026 | Cosmetic Lab, Inc. | United States | Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. |
| Feb 27, 2026 | Gallant Pet Inc | United States | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| Feb 13, 2026 | K.C. Pharmaceuticals, Inc. | United States | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| Feb 12, 2026 | Enemeez LLC | United States | Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. |
| Feb 10, 2026 | DPT Laboratories Ltd | United States | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| Jan 22, 2026 | Excel Vision | France | Written procedures are not established that describe the in-process controls and examinations to be conducted on appropriate samples of in-process materials of each batch. |
| Dec 11, 2025 | Denver Solutions, LLC | United States | Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch. |
| Nov 13, 2025 | Kindeva Drug Delivery L.P. | United States | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| Nov 4, 2025 | Grand River Aseptic Manufacturing Inc. | United States | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| Oct 31, 2025 | Active Cosmetics Manufacturing Inc | United States | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| Oct 29, 2025 | Dendreon Pharmaceuticals LLC | United States | Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. |
| Oct 24, 2025 | Frontida Biopharm, LLC | United States | Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. |
| Oct 20, 2025 | Par Health USA, LLC | United States | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| Oct 2, 2025 | OraLabs LLC | United States | Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. |
| Sep 29, 2025 | Lexia LLC | United States | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| Sep 26, 2025 | EUROSIREL S.P.A | Italy | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| Sep 19, 2025 | PEARMINE HEALTH LTD | United Kingdom | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| Aug 11, 2025 | Dee Cee Laboratories, Inc | United States | Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material… |
| Aug 11, 2025 | Dee Cee Laboratories, Inc | United States | Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch. |
Search more
Search every Form 483 citation by company with the FDA 483 search, see all frequently cited CFR sections, or check one supplier with the free FDA compliance check.