PAR OMISSION OF FAILING DATA IN VALIDATION REPORTS

Executive Summary

PAR OMISSION OF FAILING DATA IN VALIDATION REPORTS and other violations of Good Manufacturing Practices at the generic pharmaceutical firm resulted in a May 19 warning letter from FDA's Brooklyn District Office. The letter, which cites 14 types of GMP violations involving 22 products, resulted from an inspection carried out at Par's Spring Valley, N.Y. facility between January and May. The Pharmaceutical Basics, Inc. subsidiary regained eligibility for ANDA approvals on Oct. 25, two years to the day after eligibility suspension under FDA's applications integrity policy ("The Pink Sheet" Nov. 1, 1993, In Brief).