FDA Inspection 662011 — Sioux Biochemical Inc
The FDA completed an inspection of Sioux Biochemical Inc on May 19, 2010 in Sioux Center, IA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 19, 2010
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Sioux Center, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 4324 | 21 CFR 211.110(b) | In-process materials specifications testing |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4370 | 21 CFR 211.188(b)(10) | Records of any sampling performed |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |