FDA Inspection 735607 — FNC Medical Corporation
The FDA completed an inspection of FNC Medical Corporation on July 21, 2011 in Ventura, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 21, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ventura, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |