FDA DESCRIBES ON-GOING INSPECTION AND ANALYTICAL CAPABILITIES “Our primary duties have been to build relationships with FDA’s regulatory counterparts and to work with Chinese firms that want to export products to the United States,” states Christopher Hickey, Ph.D. who leads the FDA's 13-person staff in China. The office also aims to increase the number of inspections at … [Read more...]
IMPORT ALERT FINDING GREATER USAGE WITHIN FDA’S BAG OF “WEAPONS”
GULF PHARMACEUTICAL INDUSTRIES (02/23/12), NOBILUS ENT (03/07/12) and LABORATORIOS JALOMA S.A. de C.V. (03/9/12) ALL RECEIVE IMPORT ALERTS WITHIN ONE MONTH AS PART OF THEIR WARNING LETTERS The FDA has recently begun to use within their CDER Warning Letters the following terminology on a frequent basis. This includes … [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...]
CURRENT CONTRACT MANUFACTURING OPERATION (CMO) REGULATORY ISSUES (3/15/12)
FEATURING A SUMMARY OF BEN VENUE ISSUES Policy changes and enforcement strategies implemented by the FDA have led to an increase in the number of inspection of both Contract Manufacturing Operations (CMOs) and in-house sterile manufacturers — especially injectables. There has been a greater oversight and detailed review of all protocols and processes. Any issue or potential … [Read more...]
GULF PHARMACEUTICAL INDUSTRIES RECEIVES WARNING LETTER (2/23/12) RELATED TO ASEPTIC PROCESSING
TWO STRIKES AND YOU’RE OUT -- GULF PHARMA REMAINS UNDER FDA IMPORT ALERT. Gulf Pharmaceutical Industries was audited between September 25 and October 3, 2011. During this inspection, the FDA found significant violations related to aseptic processing. Several of these violations were a repetition of violations observed during a … [Read more...]
