FDA Inspection 1120153 — Packaging Unlimited LLC
The FDA completed an inspection of Packaging Unlimited LLC on February 21, 2020 in Louisville, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 21, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |