FDA Inspection 1082580 — Innova SoftGel LLC
The FDA completed an inspection of Innova SoftGel LLC on March 14, 2019 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 14, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 15500 | 21 CFR 111.27(a)(2) | Equipment - design - no contamination |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15939 | 21 CFR 111.105(g) | Quality control - reserve samples |
| 15981 | 21 CFR 111.123(a)(5) | Quality control operations - reprocessing |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |