21 CFR 211.84(d)(1) citations
FDA investigators cited 21 CFR 211.84(d)(1) 371 times at 330 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Aug 24, 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 | 28 |
| 2025 | 41 |
| 2024 | 40 |
| 2023 | 26 |
| 2022 | 13 |
| 2021 | 3 |
| 2020 | 5 |
| 2019 | 18 |
| 2018 | 16 |
| 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 |
|---|---|---|---|
| Aug 24, 2026 | Noven Pharmaceuticals, Inc. | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Aug 14, 2026 | AVEVA Drug Delivery Systems, Inc. | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Aug 12, 2026 | Steril-Gene Life Sciences Private Ltd | India | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Jul 31, 2026 | Aizant Drug Research Solutions Private Ltd. | India | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Jul 13, 2026 | Prime Enterprises LLC | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Jun 26, 2026 | Biokosmes Srl | Italy | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Jun 12, 2026 | Inspec Solutions LLC | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| May 29, 2026 | Cosmoceutical Research Center, Inc. | United States | Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed. |
| Apr 17, 2026 | Optimal Solution Labs LLC | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Apr 2, 2026 | Happy Farm Botanicals, Inc. | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Mar 26, 2026 | Westwood Laboratories, LLC. | United States | Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed. |
| Mar 23, 2026 | Dr. J Skinclinic, Inc | United States | Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed. |
| Mar 19, 2026 | PReye LLC | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Feb 27, 2026 | Gallant Pet Inc | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Feb 27, 2026 | Gasco Industrial Corp. | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Feb 19, 2026 | LICO Industries, LLC | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Feb 13, 2026 | Woodbine Products Company Inc. | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Dec 22, 2025 | Blaine Labs Inc | United States | Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed. |
| Dec 3, 2025 | Kingdomway Health Sciences LLC | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Nov 20, 2025 | J. Strickland And Co | United States | Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed. |
| Nov 19, 2025 | Vintage Chemical, Inc. | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Nov 7, 2025 | Keystone Industries | United States | Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed. |
| Oct 31, 2025 | Weckerle Cosmetics USA, INC | United States | Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed. |
| Oct 24, 2025 | Classic Cosmetics, LLC | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
| Oct 23, 2025 | SV Labs Corporation | United States | The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. |
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