FDA Inspection 867708 — HK Kolmar USA LLC
The FDA completed an inspection of HK Kolmar USA LLC on March 4, 2014 in Scott Township, PA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 4, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Scott Township, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4309 | 21 CFR 211.84(c)(2) | Containers sampled so as to prevent contamination |
| 4576 | 21 CFR 211.192 | No written record of investigation |