FDA Inspection
HK Kolmar USA LLCHK Kolmar USA LLC – FDA Inspection, Oct 16, 2012
Record Details
This FDA Inspection record concerns HK Kolmar USA LLC, with an inspection on October 16, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- HK Kolmar USA LLC
- Inspection Date
- October 16, 2012
- Product Type
- Drugs
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ID · 00776f27-c387-41cb-88c1-0c4459e7382b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 804885
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.142Written warehousing procedures established/followed
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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 20, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 18, 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 623185 - 2009-10-20
- FDA Inspection 607206 - 2009-08-18
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