FDA Inspection 874100 — Innova SoftGel LLC
The FDA completed an inspection of Innova SoftGel LLC on March 28, 2014 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 17 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 28, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1384 | 21 CFR 211.101(c) | Weighing/measuring/subdividing supervision |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15735 | 21 CFR 111.355 | Manufacturing operations - design |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |