FDA Inspection
Petscript Inc.Petscript Inc. – FDA Inspection, Sep 18, 2025
Record Details
This FDA Inspection record concerns Petscript Inc., with an inspection on September 18, 2025, issued by the Dallas District Office, covering animal drugs & feeds.
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ID · 9be5c993-0c07-4394-8b4e-2c8675286ab5
Inspection Facts
- Inspection number
- 1268183
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feeds, and Devices
FDA Citations
16- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.28(a)Clothing appropriate for duties performed
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