FDA Inspection 817179 — FNC Medical Corporation
The FDA completed an inspection of FNC Medical Corporation on November 8, 2012 in Ventura, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 8, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ventura, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |