FDA Inspection 607206 — HK Kolmar USA LLC
The FDA completed an inspection of HK Kolmar USA LLC on August 18, 2009 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 18, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Scott Township, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |