FDA Inspection 1032267 — K.C. Pharmaceuticals, Inc
The FDA completed an inspection of K.C. Pharmaceuticals, Inc on November 16, 2017 in Pomona, 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
- November 16, 2017
- Fiscal Year
- 2018
- 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 |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |