21 CFR 211.198(a) citations
FDA investigators cited 21 CFR 211.198(a) 904 times at 760 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 31, 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 | 19 |
| 2024 | 33 |
| 2023 | 13 |
| 2022 | 21 |
| 2021 | 17 |
| 2020 | 13 |
| 2019 | 52 |
| 2018 | 60 |
| 2017 | 71 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Jul 31, 2026 | Episciences Inc | United States | Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. |
| May 19, 2026 | Samchundang Pharm Co., Ltd. | Korea (the Republic of) | Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. |
| May 15, 2026 | Emcure Pharmaceuticals Limited | India | Procedures describing the handling of written and oral complaints related to drug products are not written or followed. |
| May 14, 2026 | Appco Pharma LLC | United States | Procedures describing the handling of all written and oral complaints regarding a drug product are not followed. |
| Apr 3, 2026 | MD Logistics, LLC | United States | Procedures describing the handling of all written and oral complaints regarding a drug product are not followed. |
| Apr 2, 2026 | MPP PHARMA LLC | United States | Procedures describing the handling of all written and oral complaints regarding a drug product are not established. |
| Feb 18, 2026 | CSL Behring GmbH | Germany | Procedures describing the handling of all written and oral complaints regarding a drug product are not established and followed. |
| Feb 13, 2026 | K.C. Pharmaceuticals, Inc. | United States | Procedures describing the handling of all written and oral complaints regarding a drug product are not established, written and followed. |
| Feb 5, 2026 | NexCell Scientific Inc | United States | Procedures describing the handling of all written and oral complaints regarding a drug product are not established, written and followed. |
| Feb 5, 2026 | Nice-Pak Products, LLC | United States | Procedures describing the handling of all written and oral complaints regarding a drug product are not followed. |
| Jan 21, 2026 | LPNA Group Inc. | United States | Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. |
| Dec 19, 2025 | KaryoLogic Inc | United States | Procedures describing the handling of all written and oral complaints regarding a drug product are not established and written. |
| Dec 16, 2025 | Bello Bio LLC | United States | Procedures describing the handling of all written and oral complaints regarding a drug product are not established. |
| Dec 16, 2025 | Regen Suppliers LLC | United States | Procedures describing the handling of all written and oral complaints regarding a drug product are not established. |
| Nov 21, 2025 | Spartan Chemical Co Inc | United States | Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent unexpected adverse drug experiences which are required to be reported to FDA. |
| Jul 31, 2025 | Telix IsoTherapeutics Group, Inc. | United States | Procedures describing the handling of all written and oral complaints regarding a drug product are not established and written. |
| Jul 7, 2025 | CosMedical Technologies, LLC | United States | Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. |
| Jun 4, 2025 | Perfomics Analytical Labs LLP | India | Written procedures describing the handling of complaints do not include provisions for a determination as to the need for an investigation of any unexplained discrepancy. |
| May 22, 2025 | Avadim Holdings Inc | United States | Procedures describing the handling of written and oral complaints related to drug products are not written or followed and deficiently written or followed. |
| May 16, 2025 | B. Braun Medical, Inc. | United States | Procedures describing the handling of all written and oral complaints regarding a drug product are not followed. |
| May 9, 2025 | Apotex Inc. | Canada | Procedures describing the handling of written and oral complaints related to drug products are. |
| May 2, 2025 | Osmotica Pharmaceutical US LLC | United States | Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. |
| May 1, 2025 | Best Dental Kit LLC | United States | Procedures describing the handling of written and oral complaints related to drug products are not written or followed. |
| Apr 25, 2025 | Wellbeing Medical Supply | United States | Procedures describing the handling of written and oral complaints related to drug products are not written or followed. |
| Apr 4, 2025 | Silicon Valley Innovations, Inc. | United States | Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. |
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