FDA Inspection 790155 — Dextrum Laboratories
The FDA completed an inspection of Dextrum Laboratories on July 10, 2012 in Miami, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 10, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |
| 4374 | 21 CFR 211.188(b)(6) | Inspection of packaging and labeling area |