FDA Inspection
USAntibiotics LLCFDA Inspection 1268439 - USAntibiotics LLC - April 04, 2025
Record Details
This FDA Inspection record concerns USAntibiotics LLC, with an inspection on April 4, 2025, issued by the New Orleans District Office, covering human drugs.
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ID · c774d2f8-0073-42b9-98fd-1bda86904fd2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1268439
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- FDCA 582(b)(4)Systems in place to comply with verification requirements
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Other FDA inspections of USAntibiotics LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 13, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 9, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 22, 2012 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| March 3, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for USAntibiotics LLC
- FDA Inspection 1254251 - 2024-10-17
- FDA Inspection 1116163 - 2019-12-13
- FDA Inspection 910907 - 2015-01-09
- FDA Inspection 806122 - 2012-10-22
- FDA Inspection 716446 - 2011-03-03
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