FDA Inspection 976021 — Custom Research Labs Inc
The FDA completed an inspection of Custom Research Labs Inc on June 1, 2016 in Gardena, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 1, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gardena, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1770 | 21 CFR 211.137(d) | Expiration date location on labeling |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |