FDA Inspection 1266580 — Paket Corp
The FDA completed an inspection of Paket Corp on April 10, 2025 in Chicago, IL. 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 10, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |