FDA Inspection
Steri-Pharma, LLCSteri-Pharma, LLC – FDA Inspection, Aug 8, 2025
Record Details
This FDA Inspection record concerns Steri-Pharma, LLC, with an inspection on August 8, 2025, issued by the New York District Office, covering animal drugs & feeds.
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ID · 765ccc92-d892-4ab8-ab8c-2f613a2e7d28
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1279640
- FDA center
- Animal Drugs & Feeds
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Steri-Pharma, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 4, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 24, 2017 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| October 10, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 7, 2014 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 20, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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