FDA Inspection 881454 — K.C. Pharmaceuticals, Inc.
The FDA completed an inspection of K.C. Pharmaceuticals, Inc. on May 23, 2014 in Pomona, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- May 23, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pomona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 4576 | 21 CFR 211.192 | No written record of investigation |