FDA Inspection
Tri-Med Laboratories IncTri-Med Laboratories Inc – FDA Inspection, Jun 21, 2010
Record Details
This FDA Inspection record concerns Tri-Med Laboratories Inc, with an inspection on June 21, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Tri-Med Laboratories Inc
- Inspection Date
- June 21, 2010
- Product Type
- Drugs
View Company Profile
ID · 37fdda23-e627-41e9-be1d-92fc77c6733d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 662612
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.186(b)(4)Variations in component amounts not justified
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
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 |
| September 25, 2009 | 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 613121 - 2009-09-25
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.