FDA Inspection 804885 — HK Kolmar USA LLC
The FDA completed an inspection of HK Kolmar USA LLC on October 16, 2012 in Scott Township, PA. 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 16, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Scott Township, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |