FDA Inspection 1048476 — Applied Laboratories, Inc.
The FDA completed an inspection of Applied Laboratories, Inc. on April 17, 2018 in Columbus, IN. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 17, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Columbus, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 21294 | 21 CFR 211.110(b) | In-process specification, invalid |