FDA Inspection
St. Gabriel Organics, LLCSt. Gabriel Organics, LLC – FDA Inspection, Nov 22, 2019
Record Details
This FDA Inspection record concerns St. Gabriel Organics, LLC, with an inspection on November 22, 2019, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- St. Gabriel Organics, LLC
- Inspection Date
- November 22, 2019
- Product Type
- Veterinary
View Company Profile
ID · 7c568518-7159-4e9a-8910-2e0406d2c14c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1111088
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
9- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 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 211.80(a)Procedures To Be in Writing
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Other FDA inspections of St. Gabriel Organics, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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