21 CFR 211.67(b) citations
FDA investigators cited 21 CFR 211.67(b) 1,135 times at 877 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 22, 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 | 48 |
| 2025 | 67 |
| 2024 | 58 |
| 2023 | 34 |
| 2022 | 34 |
| 2021 | 18 |
| 2020 | 27 |
| 2019 | 75 |
| 2018 | 67 |
| 2017 | 68 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Jul 22, 2026 | Neilmed Pharmaceuticals Inc | United States | Written procedures are not for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Jul 17, 2026 | I. Shay Cosmetics Inc | United States | Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the… |
| Jul 13, 2026 | Conopco Inc. D/B/A Unilever | United States | Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Jul 10, 2026 | Wasatch Product Development, LLC | United States | Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and parameters relevant to the operation. |
| Jun 19, 2026 | Nowcos Co., Ltd. | Korea (the Republic of) | Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Jun 18, 2026 | Rainbow Gold Products Inc | United States | Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Jun 12, 2026 | The Flower Remedy LLC | United States | Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| May 22, 2026 | Catalent Pharma Solutions LLC | United States | Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| May 15, 2026 | Unither Manufacturing LLC. | United States | Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| May 8, 2026 | Sombra Cosmetics, Inc | United States | Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| May 7, 2026 | Topical Pharmaceuticals, Inc. | United States | Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| May 4, 2026 | CTK OTC Laboratories LLC | United States | Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| May 1, 2026 | RAMVet LLC | United States | Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| May 1, 2026 | SnugZ USA, Inc. | United States | Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Apr 24, 2026 | Aspire Pharmaceuticals, Inc. | United States | Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Apr 2, 2026 | Baxter Healthcare Corporation | United States | Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Apr 2, 2026 | Deciem Inc. | Canada | Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Mar 23, 2026 | Dr. J Skinclinic, Inc | United States | Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Mar 20, 2026 | Eosera, Inc. | United States | Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Mar 20, 2026 | Gateway Analytical, LLC | United States | Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Mar 6, 2026 | Pharmaceutics International, Inc. | United States | Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Mar 2, 2026 | Coupler LLC | United States | Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Feb 10, 2026 | Dental Technologies, Inc. | United States | Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
| Feb 6, 2026 | Alcami Carolinas Corporation | United States | Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and instructions for removal or obliteration of previous batch identification. |
| Feb 5, 2026 | NexCell Scientific Inc | United States | Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. |
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