COMPANY CONTINUED TO FIND GRAM NEGATIVES IN PW WATER SYSTEM ID Biomedical Corp, a subsidiary of GSK Biologicals, located in Quebec, Canada was audited by the FDA from March 31 through April 9, 2014. The FDA Investigators documented deviations from CGMP in the manufacture of their biological drug product, Flulaval and its intermediates. Significant objectionable conditions … [Read more...]
FDA Warning Letters – Their Relationship to Drug Shortages
The FDA has become keenly aware within the past several years of the impact that their audits have on the availability of drugs becoming available to the consuming public. Douglas C. Throckmorton, MD, Deputy Director for Regulatory Affairs, CDER, FDA recently presented at the ISPE meeting on June 4, 2014 where he discussed this and illustrated the “FDA Response to Drug … [Read more...]
HOSPIRA – WHEN IS A DRUG RECALL AN ALERT
 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...]
BEN VENUE LABORATORIES — VOLUNTARY SHUTDOWN (11/19/11)
SHUTDOWN OCCUS AS RESULT OF SIGNIFICANT MANUFACTURING AND QUALITY CONCERNS On November 19, 2011, Ben Venue Laboratories, Inc. (“BVLâ€) announced the voluntary shutdown of manufacturing and distribution at its site in Bedford, Ohio due to significant manufacturing and quality concerns. BVL’s decision to shut down is a result … [Read more...]
