FDA Inspection
Sioux Biochemical IncSioux Biochemical Inc – FDA Inspection, May 19, 2010
Record Details
This FDA Inspection record concerns Sioux Biochemical Inc, with an inspection on May 19, 2010, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Sioux Biochemical Inc
- Inspection Date
- May 19, 2010
- Product Type
- Veterinary
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ID · f4c512e8-103e-491b-aba4-8ed1d47ac957
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 662011
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
15- 21 CFR 211.188(b)(10)Records of any sampling performed
- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.110(b)In-process materials specifications testing
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
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Other FDA inspections of Sioux Biochemical Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2026 | NAI | Food Composition, Standards, Labeling and Econ | |
| June 16, 2015 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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