FDA Inspection 1034458 — Thermo-Pak Company, Inc.
The FDA completed an inspection of Thermo-Pak Company, Inc. on December 7, 2017 in Wood Dale, IL. 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
- December 7, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wood Dale, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2406 | 21 CFR 211.194(a)(8) | Identification of Person Performing Review of Lab Records |