FDA Inspection 759932 — S&B Pharma LLC
The FDA completed an inspection of S&B Pharma LLC on Dec 16, 2011 in Fenton, MO. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 16, 2011
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- 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 |