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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
January 31, 2014 Huwen Huang Import And Export Sa Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
January 30, 2014 Amber Technology, LLC Denver District Office New Animal Drug/Adulterated Not Issued *
January 30, 2014 Manuel and Maria Silva Dairy San Francisco District Office New Animal Drug/Adulterated Not Issued *
January 29, 2014 Hillegass Dairy, LLC. Philadelphia District Office Illegal Drug Residue Not Issued *
January 29, 2014 ConMed Electrosurgery Denver District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
January 29, 2014 Campbell Dairy Farm New Orleans District Office Illegal Drug Residue Not Issued *
January 29, 2014 Insert Depot, Inc Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
January 28, 2014 B & E Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
January 28, 2014 Hudson Radiology Center New Jersey District Office Mammography Quality Standards Not Issued *
January 27, 2014 Seorak Clean Food Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
January 27, 2014 Amgen, Inc. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
January 24, 2014 C.S.O. S.R.L. Center for Devices and Radiological Health Medical Device Reporting/Adulterated/Misbranding August 18, 2014
January 23, 2014 Pacific Standard Distributors, inc Seattle District Office Internet Marketing of Unapproved and Misbranded Drugs Not Issued *
January 23, 2014 Mongiello Italian Cheese Specialties, Inc. dba Formaggio New York District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   August 18, 2014
January 23, 2014 Cotton High Tech S.L. (d/ba COHITECH) Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated/Misbranded Not Issued *
January 22, 2014 Zubrzycki Homestead New York District Office Illegal Drug Residue Not Issued *
January 22, 2014 Stanton Brothers Kansas City District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
January 22, 2014 Home Intensive Care Pharmacy, Inc. Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
January 22, 2014 Intensive Nutrition Incorporated San Francisco District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
January 21, 2014 Oskri Corp. Minneapolis District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *



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