FDA Inspection
HK Kolmar USA LLCHK Kolmar USA LLC – FDA Inspection, Aug 18, 2009
Record Details
This FDA Inspection record concerns HK Kolmar USA LLC, with an inspection on August 18, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- HK Kolmar USA LLC
- Inspection Date
- August 18, 2009
- Product Type
- Drugs
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ID · 82db6eea-f6ef-40e1-9ec7-47e0686adbf0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 607206
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.125(c)Label reconciliation discrepancies evaluation/investigation
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Other FDA inspections of HK Kolmar USA LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 8, 2017 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| March 4, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 16, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 20, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for HK Kolmar USA LLC
- FDA Inspection 1229516 - 2024-02-09
- FDA Inspection 1031330 - 2017-09-08
- FDA Inspection 867708 - 2014-03-04
- FDA Inspection 804885 - 2012-10-16
- FDA Inspection 623185 - 2009-10-20
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