Baker Cummins Pharmaceuticals
Receives June 30 warning letter from FDA following a June 1-18 inspection of the firm's Willen Drug Division in Baltimore. FDA says it found deficiencies "concerning the responsibilities of the quality control unit, personnel qualifications, buildings and facilities, equipment cleaning and maintenance, drug component control, production and process control, label control, laboratory controls and stability testing." The agency issued an FD-483 following the inspection. The firm characterizes the observations as pertaining to recordkeeping deficiencies and notes it has begun revamping the SOPs at Willen Drug. Baker Cummins parent Ivax acquired Willen Drug, a marketer of generic urological products, in December.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth