FDA Inspection 1106079 — KarePak, LLC
The FDA completed an inspection of KarePak, LLC on October 9, 2019 in Oakdale, CA. 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
- October 9, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Oakdale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |