FDA Inspection 665651 — FNC Medical Corporation
The FDA completed an inspection of FNC Medical Corporation on June 11, 2010 in Ventura, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 11, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ventura, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |