FDA Inspection
AG Essence, Inc.AG Essence, Inc. – FDA Inspection, Feb 26, 2025
Record Details
This FDA Inspection record concerns AG Essence, Inc., with an inspection on February 26, 2025, issued by the Baltimore District Office, covering animal drugs & feeds.
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ID · ed3c0229-d273-4943-925f-b1944f37dc7b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1262267
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feeds, and Devices
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.84(d)(2)Component identification test
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Other FDA inspections of AG Essence, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 11, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 17, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 14, 2015 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 16, 2012 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for AG Essence, Inc.
- FDA Inspection 1227772 - 2024-01-22
- FDA Inspection 1093209 - 2019-06-11
- FDA Inspection 989080 - 2016-06-17
- FDA Inspection 920350 - 2015-05-14
- FDA Inspection 801732 - 2012-10-16
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