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.