FDA Inspection
Tri-Med Laboratories IncTri-Med Laboratories Inc – FDA Inspection, Sep 25, 2009
Record Details
This FDA Inspection record concerns Tri-Med Laboratories Inc, with an inspection on September 25, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Tri-Med Laboratories Inc
- Inspection Date
- September 25, 2009
- Product Type
- Drugs
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ID · 8f3017ee-d1c2-4437-974c-a2704634590c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 613121
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Tri-Med Laboratories Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2010 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Tri-Med Laboratories Inc
- FDA Inspection 725031 - 2011-05-18
- FDA Inspection 662612 - 2010-06-21
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