FDA Inspection
Sioux Biochemical IncSioux Biochemical Inc – FDA Inspection, Jun 16, 2015
Record Details
This FDA Inspection record concerns Sioux Biochemical Inc, with an inspection on June 16, 2015, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Sioux Biochemical Inc
- Inspection Date
- June 16, 2015
- Product Type
- Veterinary
View Company Profile
ID · dcffde17-6dc1-45cd-ba90-0a1ba9fffbbe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 929237
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
10- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.137(a)Expiration date lacking
- 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 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sioux Biochemical Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2026 | NAI | Food Composition, Standards, Labeling and Econ | |
| May 19, 2010 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Sioux Biochemical Inc
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.