FDA Inspection 1009116 — Pratt Midwest Display LLC
The FDA completed an inspection of Pratt Midwest Display LLC on April 26, 2017 in West Chester, OH. 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 26, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Chester, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 4374 | 21 CFR 211.188(b)(6) | Inspection of packaging and labeling area |