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FDA Inspection
•Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs•August 6, 2010

Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs – FDA Inspection, Aug 6, 2010

Record Details

This FDA Inspection record concerns Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs, with an inspection on August 6, 2010, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs
Inspection Date
August 6, 2010
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · d9ccabdf-27b4-4893-b339-95f50ed8dd93

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
675997
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards

FDA Citations

42
  1. 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
  2. 21 CFR 211.58Buildings not maintained in good state of repair
  3. 21 CFR 211.110(a)Control procedures to monitor and validate performance
  4. 21 CFR 211.63Equipment Design, Size and Location
  5. 21 CFR 211.25(a)GMP Training Frequency
  6. 21 CFR 211.160(b)Scientifically sound laboratory controls
  7. 21 CFR 111.12(c)Personnel - education, training, experience
  8. 21 CFR 211.68(a)Written calibration / inspection records not kept
  9. 21 CFR 211.84(b)Representative Samples
  10. 21 CFR 211.165(a)Testing and release for distribution

Showing 10 of 42 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs

4
DateClassificationOfficeProject area
June 16, 2014OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 15, 2013OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
September 12, 2012OAICenter for Drug Evaluation and ResearchUnapproved and Misbranded Drugs
June 16, 2011VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Titan Medical Enterprises, Inc. DBA U.S. Apothecary Labs
  • FDA Inspection 885391 - 2014-06-16
  • FDA Inspection 814630 - 2013-01-15
  • FDA Inspection 799505 - 2012-09-12
  • FDA Inspection 727470 - 2011-06-16

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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