FDA Inspection
HK Kolmar Canada, Inc.HK Kolmar Canada, Inc. – FDA Inspection, Sep 29, 2017
Record Details
This FDA Inspection record concerns HK Kolmar Canada, Inc., with an inspection on September 29, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0a7e3278-a61e-40ba-a2d8-26aa16993b2a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027545
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of HK Kolmar Canada, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| November 1, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 21, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 20, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for HK Kolmar Canada, Inc.
- FDA Inspection 1271803 - 2025-06-05
- FDA Inspection 1114552 - 2019-11-01
- FDA Inspection 940515 - 2015-08-21
- FDA Inspection 853300 - 2013-09-20
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