FDA Inspection 1221284 — Applied Laboratories, Inc.
The FDA completed an inspection of Applied Laboratories, Inc. on October 27, 2023 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
- October 27, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Columbus, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |