FDA Inspection 1009808 — BioChroma Analytical Labs, LLC.
The FDA completed an inspection of BioChroma Analytical Labs, LLC. on February 8, 2017 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 8, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |