FDA Inspection 711197 — K.C. Pharmaceuticals, Inc
The FDA completed an inspection of K.C. Pharmaceuticals, Inc on February 14, 2011 in Pomona, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 14, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pomona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |