Baker Cummins Pharmaceuticals

Executive Summary

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.