FDA Inspection
Pathogenes, Inc.Pathogenes, Inc. – FDA Inspection, Apr 24, 2019
Record Details
This FDA Inspection record concerns Pathogenes, Inc., with an inspection on April 24, 2019, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 00412ee3-7a6e-49c5-a9c2-423693fb7282
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087268
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.150Written distribution procedure
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Other FDA inspections of Pathogenes, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 25, 2022 | VAI | Center for Veterinary Medicine | Bioresearch Monitoring |
| March 11, 2016 | OAI | Center for Veterinary Medicine | Bioresearch Monitoring |
Other documents for Pathogenes, Inc.
- FDA Inspection 1191664 - 2022-11-25
- FDA Inspection 962076 - 2016-03-11
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