FDA RECOMMENDS ALERT TO AVOID DRUG SHORTAGES In a previous Blog (May 24, 2012) the issue of Warning Letters and how the FDA now on a routine basis is asking their Clients to advise them if the Warning Letter and its consequences will result in shortages was discussed. In this Blog, the FDA is using “Risk Management†… [Read more...]
NUSIL TECHNOLOGY LLC RECEIVES FDA WARNING LETTER (032312)
API MFG CITED FOR OOS AND MICROBIOLOGICAL ISSUES (B. cepacia) -- REFERENCES RECENT PDA J. PHARM SCI & TECH 1. Your firm failed to have an adequate out-of-specification (OOS) procedure to conduct thorough and scientifically sound investigations including corrective actions. For example, the OOS report number (b)(4) for lot (b)(4) of Simethicone Emulsion USP … [Read more...]
FDA RELEASES “GLOBAL ENGAGEMENT REPORT” (4/23/12)
NEW REPORT PRESENTS FDA's FOCUS ON GLOBAL COOPERATION FOR PRODUCT SAFETY The U.S. FDA Commissioner Margaret A. Hamburg, MD released the Agency's "Global Engagement Report" detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency. This report describes the steps the Agency is taking to ensure the imported food, … [Read more...]
FDA’S CHINA OFFICE FOCUSES ON REGULATORY ACTIVITIES (4/4/12)
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...]
BEN VENUE DETERMINES SIGNIFICANT REMEDIATION REQUIRED AT ITS BEDFORD, OHIO FACILITIES
"NORTH" FACILITY MAY NOT BE AVAILABLE FOR MFG OF STERILE INJECTABLES BEFORE 4th QUARTER 2012 COMMENT Ben Venue Laboratories issued an early "Christmas gift" press release on Friday, December 23 wherein they announced the decision to extend the voluntary suspension of manufacturing at its Bedford, OH facility. Ben Venue has determined that it can no longer both … [Read more...]
