FDA Inspection
St. Gabriel Organics, LLCSt. Gabriel Organics, LLC – FDA Inspection, Jun 1, 2017
Record Details
This FDA Inspection record concerns St. Gabriel Organics, LLC, with an inspection on June 1, 2017, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · eef4c352-6bdd-44df-a692-376d2000997d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013117
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of St. Gabriel Organics, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 22, 2019 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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