FDA Inspection 1014745 — Laboratory Corporation of America
The FDA completed an inspection of Laboratory Corporation of America on June 19, 2017 in Tampa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 19, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |