FDA Inspection
Labomar Canada IncLabomar Canada Inc – FDA Inspection, Dec 15, 2016
Record Details
This FDA Inspection record concerns Labomar Canada Inc, with an inspection on December 15, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a2c4d7cd-5439-45a1-a900-258d63499c8e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 998477
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.89Quarantine of Rejected Components et. al.
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Labomar Canada Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 5, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 2, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 13, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Labomar Canada Inc
- FDA Inspection 1249452 - 2024-08-09
- FDA Inspection 1073370 - 2018-11-09
- FDA Inspection 887471 - 2014-06-05
- FDA Inspection 763073 - 2011-12-02
- FDA Inspection 605450 - 2009-08-13
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