21 CFR 211.180(e)(2) citations
FDA investigators cited 21 CFR 211.180(e)(2) 436 times at 361 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 17, 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 | 10 |
| 2025 | 20 |
| 2024 | 10 |
| 2023 | 10 |
| 2022 | 9 |
| 2021 | 6 |
| 2020 | 12 |
| 2019 | 27 |
| 2018 | 29 |
| 2017 | 41 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Jul 17, 2026 | I. Shay Cosmetics Inc | United States | Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug… |
| May 7, 2026 | Topical Pharmaceuticals, Inc. | United States | Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug… |
| May 1, 2026 | Best Sanitizers Inc | United States | Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug… |
| Apr 3, 2026 | MD Logistics, LLC | United States | Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products. |
| Mar 26, 2026 | Cosmetics & Cleaners International LLC | United States | Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug… |
| Mar 20, 2026 | Omega & Delta Co., Inc. | United States | Written procedures are not followed for evaluations done at least annually and including provisions for a review of investigations conducted for each drug product. |
| Jan 21, 2026 | LPNA Group Inc. | United States | Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of complaints and investigations conducted for each drug product. |
| Jan 16, 2026 | Custom Converting, Inc. | United States | Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug… |
| Dec 18, 2025 | MassBiologics | United States | Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug… |
| Oct 16, 2025 | Liquipak Corporation | United States | Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug… |
| Sep 15, 2025 | Pharbest Pharmaceuticals, Inc. | United States | The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of records for each drug product. |
| Sep 4, 2025 | United-Guardian, Inc. | United States | Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug… |
| Aug 22, 2025 | HTO Nevada Inc. | United States | Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products. |
| Aug 11, 2025 | Dee Cee Laboratories, Inc | United States | The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of complaint, recall, returned drug product, salvaged drug product and investigation records for each… |
| Jun 23, 2025 | Private Label Skin Care | United States | Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products. |
| Jun 18, 2025 | Sheffield Pharmaceuticals, LLC | United States | Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug… |
| May 16, 2025 | B. Braun Medical, Inc. | United States | Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products. |
| May 9, 2025 | Charlotte Products Ltd. | Canada | Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug… |
| May 2, 2025 | Naturich Cosmetique Labs | United States | The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of investigation records for each drug product. |
| Apr 14, 2025 | RemedyRePack Inc. | United States | Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products. |
| Apr 3, 2025 | Kath Khemicals LLC | United States | Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug… |
| Mar 14, 2025 | Acuity Specialty Products, Inc. | United States | Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug… |
| Mar 14, 2025 | Chae Organics LLC | United States | Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products. |
| Feb 27, 2025 | ABBE Laboratories, Inc. | United States | Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug… |
| Jan 21, 2025 | GenIbet Biopharmaceuticals, S.A. | Portugal | Written procedures are not established for evaluations done at least annually and including provisions for a review of investigations conducted for each drug product. |
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