FDA Inspection
Titan Medical Enterprises, Inc. DBA U.S. Apothecary LabsTitan Medical Enterprises, Inc. DBA U.S. Apothecary Labs – FDA Inspection, Jun 16, 2011
Record Details
This FDA Inspection record concerns Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs, with an inspection on June 16, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 16, 2011
- Product Type
- Drugs
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ID · f0c8fd62-3b0c-4800-a0cd-6735b26a0cc2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 727470
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
40- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 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 211.110(a)Control procedures fail to include the following
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 111.12(c)Personnel - education, training, experience
- 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
- 21 CFR 211.115(a)Reprocessing procedures lack steps to be taken
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Other FDA inspections of Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 |
| August 6, 2010 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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