CGMP Deviations Found in Mylan Unit 8

A 5/27-6/5 FDA inspection at Mylan Laboratories’ Unit 8, Andhra Pradesh, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). An 11/5 Warning Letter says specific violations were: 

•          failing to have adequate written procedures for the receipt, identification, and handling of raw materials; and
•          failing to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the APIs beyond the official or other established specifications.

The letter says FDA strongly recommends that the firm engage a qualified consultant to evaluate its operation and assist it in meeting CGMP requirements. Mylan was told to respond with a list of specific steps taken since the inspection to correct the deviations and prevent their recurrence, with a schedule for completion of the steps.