FDA Inspection
HK Kolmar USA LLCHK Kolmar USA LLC – FDA Inspection, Oct 20, 2009
Record Details
This FDA Inspection record concerns HK Kolmar USA LLC, with an inspection on October 20, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- HK Kolmar USA LLC
- Inspection Date
- October 20, 2009
- Product Type
- Drugs
View Company Profile
ID · 47917d79-b9f4-47a9-91d3-087f8799b7e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 623185
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.100(a)Absence of Written Procedures
Full citation text and observation details available on the Dashboard.
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 |
| 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 804885 - 2012-10-16
- FDA Inspection 607206 - 2009-08-18
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