FDA Inspection 700497 — Applied Laboratories, Inc.
The FDA completed an inspection of Applied Laboratories, Inc. on October 18, 2010 in Columbus, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 18, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Columbus, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |