FDA Inspection 1092666 — RNV LLC
The FDA completed an inspection of RNV LLC on June 17, 2019 in Miami Lakes, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 17, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami Lakes, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 15521 | 21 CFR 111.27(d)(6) | Cleaning compounds - adequate, safe |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 18151 | 21 CFR 117.40(f) | Instruments and Controls |
| 19066 | 21 CFR 117.165(b) | Sanitation Controls Verif Procedures: Establish Implement |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |