FDA Inspection 674198 — Sanitor Corporation
The FDA completed an inspection of Sanitor Corporation on August 5, 2010 in Stanton, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 5, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Stanton, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4576 | 21 CFR 211.192 | No written record of investigation |