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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2010 Warning Letters

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Warning Letters issued in 2010

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 17, 2010 Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc. Los Angeles District Office CGMP for Medical Devices/Adulterated Not Issued *
May 13, 2010 Jilin Shulan Synthetic Pharmaceutical Co. Ltd. Center for Drug Evaluation and Research CGMP for Deviations/Adulterated May 31, 2012
May 12, 2010 Cogent Solutions Group LLC Cincinnati District Office New Drug/Labeling/Misbranded March 30, 2011
May 12, 2010 CMC Commodity Transport Inc. Atlanta District Office Animal Feed/Adulterated with shredded tire chips Not Issued *
May 12, 2010 Terry Yon & Associates, Inc./dba Tya Pharmaceuticals Florida District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
May 12, 2010 Laboratorios L.O., Oftalmi, C.A. Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
May 12, 2010 Miller, David L. New York District Office Illegal Drug Residue Not Issued *
May 11, 2010 Artegraft, Inc. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated March 23, 2011
May 11, 2010 Molteno Ophthalmic Ltd Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded August 22, 2011
May 11, 2010 Healthy World Distributing Seattle District Office Promotional Claims/Misbranded Not Issued *
May 10, 2010 Dolce, L.L.C. Cincinnati District Office Seafood HACCP/Insanitary Conditions/Adulterated Not Issued *
May 10, 2010 Service Smoked Fish Corp New York District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
May 10, 2010 Willamette Shelling Inc Seattle District Office CGMP Regulation For Food/Adulterated Not Issued *
May 10, 2010 Len-acres Seattle District Office Illegal Drug Residue Not Issued *
May 10, 2010 Aurora Ridge Dairy, LLC New York District Office Illegal Drug Residue Not Issued *
May 10, 2010 Braintree Laboratories Inc New England District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated April 27, 2011
May 10, 2010 Midstate Veterinary Services, PLLC New York District Office Illegal Drug Residue Not Issued *
May 07, 2010 Medtronic Navigation, Inc Denver District Office Medical Device/Lacks Premarket Approval/Adulterated/Misbranded Not Issued *
May 06, 2010 C.V. Foods Corporation, DBA Yo Lily Cheesecake Co. Los Angeles District Office CGMP Requirement for Food Manufacturing/Adulterated Not Issued *
May 03, 2010 Trilliant Surgical, LTD Dallas District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded August 17, 2012



 

Contact FDA

FDA's Office of Critical Path and Regulatory Science Initiatives

Frank F. Weichold, MD, PhD

Acting Director

Critical Path and Regulatory Science Initiatives

301-796-8187

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