FDA Inspection 923526 — K.C. Pharmaceuticals, Inc.
The FDA completed an inspection of K.C. Pharmaceuticals, Inc. on Mar 19, 2015 in Pomona, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 19, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pomona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 3640 | 21 CFR 211.204 | Returned drug products identified and held |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |