21 CFR 211.100(a) citations
FDA investigators cited 21 CFR 211.100(a) 1,781 times at 1,329 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 3, 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 | 72 |
| 2025 | 154 |
| 2024 | 118 |
| 2023 | 80 |
| 2022 | 84 |
| 2021 | 44 |
| 2020 | 47 |
| 2019 | 99 |
| 2018 | 84 |
| 2017 | 102 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Sep 3, 2026 | USpharma, Ltd., Co. | United States | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Aug 20, 2026 | PD-Rx Pharmaceuticals, Inc. | United States | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Aug 12, 2026 | A-S Medication Solutions LLC | United States | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Aug 12, 2026 | Steril-Gene Life Sciences Private Ltd | India | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Jul 29, 2026 | LTS Lakewood, LLC | United States | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Jul 14, 2026 | Aspen SA Sterile Operations (Pty) Ltd. | South Africa | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Jun 26, 2026 | Advanced Cosmetic Research Laboratories, Inc. | United States | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Jun 26, 2026 | S.S.S. Company (International) | United States | Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to… |
| Jun 12, 2026 | Product Society LLC | United States | Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to… |
| Jun 12, 2026 | The Flower Remedy LLC | United States | Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to… |
| May 27, 2026 | API Solutions Inc. | United States | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| May 19, 2026 | Samchundang Pharm Co., Ltd. | Korea (the Republic of) | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| May 8, 2026 | Sombra Cosmetics, Inc | United States | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| May 7, 2026 | Topical Pharmaceuticals, Inc. | United States | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| May 5, 2026 | Zydus Lifesciences Limited | India | Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to… |
| May 1, 2026 | GVS TM, Inc | United States | Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to… |
| Apr 27, 2026 | Similasan AG | Switzerland | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Apr 24, 2026 | Hanlim Pharm Co. Ltd. | Korea (the Republic of) | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Apr 22, 2026 | Alcami Carolinas Corporation | United States | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Apr 22, 2026 | Hyland's Consumer Health Inc. | United States | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Apr 21, 2026 | Altaire Pharmaceuticals, Inc. | United States | Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to… |
| Apr 20, 2026 | New SPS Crossfolds, LLC | United States | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Apr 14, 2026 | Rohto-Mentholatum (Vietnam) Co., Ltd. | Vietnam | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Apr 8, 2026 | Padagis US LLC | United States | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
| Apr 2, 2026 | Happy Farm Botanicals, Inc. | United States | Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or… |
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