Foreign bulk manufacturers receive at least 16 warning letters in five months from March 1-Aug. 1.

FOREIGN BULK PHARMACEUTICAL MANUFACTURERS RECEIVE 16 cGMP WARNING LETTERS from FDA in the five months ending Aug. 1. In inspections dating from October 1994 to May 1995, FDA documented significant current Good Manufacturing Practices deviations by foreign BPC manufacturers. Lack of process validation repeatedly was cited as a cGMP violation throughout the warning letters. Validation of water systems, drying methods, impurity profile determinations, blending and cleaning were among the violations noted.