FDA Inspection 675151 — CPC Laboratories Inc
The FDA completed an inspection of CPC Laboratories Inc on Aug 18, 2010 in Chicago, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 18, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3588 | 21 CFR 211.110(a)(3) | Mixing adequacy |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |