Thursday 2 February 2012

FDA Warning Letters

Posted on January 31, 2012

Letter Issue Date Company Name Issuing Office Subject Close Out Date
January 23, 2012 Douty Brothers, Inc.32 New England District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
January 23, 2012 Negocios Industriales Real "N.I.R.S.A.", S.A.33 Center for Food Safety and Applied Nutrition CGMP Regulation For Food/Adulterated Not Issued *
January 18, 2012 Almased USA, Inc.34 Florida District Office Dietary Supplement/Labeling/False & Misleading Claims/Misbranded Not Issued *
January 13, 2012 LeCaptain, Mark D.35 Minneapolis District Office Illegal Drug Residue Not Issued *
January 12, 2012 Augusta Medical Systems, LLC36 Atlanta District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
January 04, 2012 Flavors from Florida, Inc.37 Florida District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
December 23, 2011 APC Medical Limited38 Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
December 23, 2011 Go Medical Industries Pty., Ltd.39 Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 23, 2011 Teh Lin Prosthetic & Orthopedic, Inc.40 Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
December 21, 2011 Integra LifeSciences Corporation41 New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 15, 2011 Labor L+S AG42 Center for Drug Evaluation and Research CGMP for Finished Pharmaceutical/Adulterated Not Issued *
August 02, 2011 Sorin Group Deutschland GmbH43 Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
August 01, 2011 Pacific Cheese Company, Inc.44 San Francisco District Office Food/Adulterated Not Issued *
* 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.

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