Mylan Laboratories Limited – FDA EIR, Feb 1, 2017

An FDA inspection of Mylan Laboratories Limited's Research and Development (R&D) contract testing laboratory in Bollaram, Telangana, India, was conducted from January 24 to February 1, 2017. This initial, unannounced for-cause inspection, carried out under compliance programs 7356.002 and PAC 56002 for Drug Manufacturing Inspections, aimed to evaluate the facility's operations. The facility functions as a contract testing laboratory, developing analytical method validations for finished dosage forms and Active Pharmaceutical Ingredients (APIs) and supporting Mylan's commercial manufacturing sites in India. Consequently, it is subject to the adulteration provisions of section 501(a)(2)(b) of the Food Drug and Cosmetic Act, mandating adherence to current Good Manufacturing Practices (cGMP).At the conclusion of the inspection, a Form FDA 483 was issued, detailing four significant deficiencies. These included a lack of appropriate controls over computer systems, incomplete laboratory records, improper storage conditions for drug products, and unwritten responsibilities and procedures for the quality control unit. Specifically, inspectors noted missing raw data for seven API analytical method validations and observed instances of weight printouts discarded rather than retained. Furthermore, the firm's quality unit failed to validate the network and server for chromatographic data storage, and bioequivalence samples were stored without appropriate environmental monitoring.In response, Mr. Sanjeev Sethi, Chief Scientific Officer, acknowledged these observations and committed to implementing corrections, promising a written response to the FDA within 15 business days. Notably, during the inspection, Mylan Laboratories Limited also withdrew six Drug Master File (DMF) applications for Active Pharmaceutical Ingredients due to the absence of associated raw data for method validations.