FDA Inspection
Titan Medical Enterprises, Inc. DBA U.S. Apothecary LabsTitan Medical Enterprises, Inc. DBA U.S. Apothecary Labs – FDA Inspection, Jun 16, 2014
Record Details
This FDA Inspection record concerns Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs, with an inspection on June 16, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 16, 2014
- Product Type
- Drugs
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ID · 9c868e3b-5c6f-4104-9135-adba01033112
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 885391
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
19- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 15, 2013 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 12, 2012 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| June 16, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 6, 2010 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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