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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2014 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 21, 2014 Greer Laboratories Inc Office of Regulatory Affairs CGMP Deviations  Not Issued *
April 21, 2014 Labotech Microscopes India Private Limited Center for Devices and Radiological Health Medical Device Reporting/Adulterated/Misbranding Not Issued *
April 18, 2014 Pancrazio S.P.A. Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated Not Issued *
April 18, 2014 Iowa Select Herbs Kansas City District Office New Drug/Labeling/Misbranded/CGMP/Adulterated Not Issued *
April 18, 2014 Rogerio Lobo, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
April 17, 2014 CDJ Holding, Inc., DBA Pacific BioLogic Co. San Francisco District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
April 17, 2014 Mar Cor Purification Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 17, 2014 Hahn's Old Fashioned Cake Company, Inc. New York District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/Misbranded Not Issued *
April 17, 2014 Biondillo's Bakery Chicago District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/Misbranded   Not Issued *
April 16, 2014 Instituto Bioclon, S.A. de C.V. Center for Biologics Evaluation and Research CGMP Deviations Not Issued *
April 15, 2014 Cook Vascular Inc. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k); Promotion and Advertising/Misleading/Misbranded Not Issued *
April 11, 2014 Han Yang Oriental Food Mfg Seattle District Office Food CGMP Violations Not Issued *
April 11, 2014 SANUM-Kehlbeck GmbH & Co. KG Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
April 11, 2014 Sanmina-SCI AB Center for Devices and Radiological Health Medical Devices/Adulterated/Quality System Regulation (QSR) August 07, 2014
April 10, 2014 AMKS TIME RELEASE LAB, LLC Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization Not Issued *
April 10, 2014 Montana Fish Company Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 10, 2014 American Medical Systems, Inc. Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 09, 2014 Pereira's Dairy Farm New York District Office Illegal Drug Residue Not Issued *
April 09, 2014 Sunrise Meats, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Misbranded Not Issued *
April 09, 2014 Boyko Foods, LLC Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *



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