21 CFR 211.166(a) citations
FDA investigators cited 21 CFR 211.166(a) 1,125 times at 904 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 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 | 31 |
| 2025 | 57 |
| 2024 | 63 |
| 2023 | 33 |
| 2022 | 48 |
| 2021 | 29 |
| 2020 | 29 |
| 2019 | 82 |
| 2018 | 73 |
| 2017 | 79 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Jul 23, 2026 | Fuller Industries Inc | United States | Results of stability testing are not used in determining appropriate storage conditions and expiration dates. |
| Jun 26, 2026 | S.S.S. Company (International) | United States | The written stability testing program is not followed. |
| Jun 19, 2026 | Nowcos Co., Ltd. | Korea (the Republic of) | The written stability testing program is not followed. |
| Jun 12, 2026 | Inspec Solutions LLC | United States | There is no written testing program designed to assess the stability characteristics of drug products. |
| Jun 12, 2026 | Product Society LLC | United States | There is no written testing program designed to assess the stability characteristics of drug products. |
| Jun 9, 2026 | The Procter & Gamble Manufacturing Company | United States | The written stability testing program is not followed. |
| May 15, 2026 | Unither Manufacturing LLC. | United States | There is no written testing program designed to assess the stability characteristics of drug products. |
| May 8, 2026 | PPL Healthcare LLC | United States | The written stability testing program is not followed. |
| May 8, 2026 | Sombra Cosmetics, Inc | United States | There is no written testing program designed to assess the stability characteristics of drug products. |
| May 1, 2026 | Best Sanitizers Inc | United States | The written stability testing program is not followed. |
| Apr 29, 2026 | Samson Pharmaceuticals, Inc | United States | There is no written testing program designed to assess the stability characteristics of drug products. |
| Apr 24, 2026 | Hanlim Pharm Co. Ltd. | Korea (the Republic of) | Results of stability testing are not used in determining expiration dates. |
| Apr 20, 2026 | New SPS Crossfolds, LLC | United States | There is no written testing program designed to assess the stability characteristics of drug products. |
| Apr 3, 2026 | Granules Pharmaceuticals Inc. | United States | The written stability testing program is not followed. |
| Mar 23, 2026 | Dr. J Skinclinic, Inc | United States | Results of stability testing are not used in determining appropriate storage conditions and expiration dates. |
| Mar 5, 2026 | Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil | Turkey | The written stability testing program is not followed. |
| Feb 27, 2026 | Brio Pharmaceuticals Inc | United States | The written stability testing program is not followed. |
| Feb 27, 2026 | Gasco Industrial Corp. | United States | There is no written testing program designed to assess the stability characteristics of drug products. |
| Feb 27, 2026 | Tan-Alize Kozmetik Ve Temizlik Urunleri Sanayi Ve Ticaret A.S. | Turkey | The written stability testing program is not followed. |
| Jan 28, 2026 | Hit Promotional Products Inc. | United States | There is no written testing program designed to assess the stability characteristics of drug products. |
| Jan 15, 2026 | FairyGene, Inc. | United States | There is no written testing program designed to assess the stability characteristics of drug products. |
| Jan 12, 2026 | Skytronics Led, Inc | United States | There is no written testing program designed to assess the stability characteristics of drug products. |
| Dec 16, 2025 | Bello Bio LLC | United States | There is no written testing program designed to assess the stability characteristics of drug products. |
| Nov 21, 2025 | Sato Pharmaceutical Co., Ltd. | Japan | The written stability testing program is not followed. |
| Nov 18, 2025 | Chartwell Pharmaceuticals Congers, LLC | United States | The written stability testing program is not followed. |
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