FDA Inspection 759932 — S&B Pharma LLC
The FDA completed an inspection of S&B Pharma LLC on December 16, 2011 in Fenton, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 16, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fenton, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |