Chemolee Lab Corporation Receives Warning Letter (022316) (Click Here) Investigators from the U.S. Food and Drug Administration (FDA) inspected Chemolee Lab Corporation, located at 3820 Conflans Road, Irving, Texas from January 12 thru February 13, 2015 and found a number of CGMP violations for exceeding microbial specifications. These included: Your firm failed to … [Read more...]
FIRM REPEATLY DECLINES TO RECALL ITS STERILE PRODUCTS
IS THIS THE NEW “POSTER CHILD†FOR NON-COMPLIANCE? On Friday, August 16, 2013 the FDA issued a News Release wherein it reminded “health care providers not to use sterile products from NuVision Pharmacyâ€. The FDA indicated that the rationale behind the News Release was because the … [Read more...]
AMERIDOSE, LLC RECEIVES 15 OBSERVATIONS AS PART OF FORM FDA 483 (11/09/12)
SISTER COMPANY OF NECC RECEIVES TWENTY PAGE 483 CONTAINING SEVERAL REPEAT OBSERVATIONS COMMENT The FDA conducted an inspection of Ameridose, LLC, Westborough, MA from October 10 through November 9, 2012. The investigation, involved fourteen Investigators and three microbiologists including one microbiologist from CDER. A total of fifteen Observations including several … [Read more...]
WINTAC LIMITED INDIA RECEIVES FDA WARNING LETTER (022312)
CITES ASEPTIC MANUFACTURING FACILITY FOR SIGNIFICANT cGMP VIOLATIONS Specific violations observed during the inspection include, but are not limited, to the following: 1. Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile. Such procedures shall include validation of … [Read more...]
MERCK KGaA RECEIVES WARNING LETTER (12/15/11)
FDA INCLUDES THREE EUROPEAN FACILITIES TO INCLUDE MERCK SERONO S.A., AUBONNE, SWITZERLAND WITH MEDIA FILL ISSUES The FDA released on Wednesday, February 17, 2012 a Warning Letter that was sent to Merck KGaA on December 15, 2011. Within the Warning Letter the FDA advised Merck KGaA management of deficiencies at three separate facilities, two in Switzerland and one in Rome, … [Read more...]
