FDA Inspection 1247201 — K.C. Pharmaceuticals, Inc.
The FDA completed an inspection of K.C. Pharmaceuticals, Inc. on Aug 28, 2024 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 28, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pomona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |