FDA Inspection 829266 — Concept Laboratories, Inc.
The FDA completed an inspection of Concept Laboratories, Inc. on April 19, 2013 in Pleasant Prairie, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 19, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pleasant Prairie, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |