FDA EIR - Mylan Pharmaceuticals Inc. - November 09, 2018

The FDA conducted a five-day analytical surveillance inspection of Mylan Pharmaceuticals, Inc. in Morgantown, WV, from November 5-9, 2018. This inspection, authorized under the Federal Food, Drug, and Cosmetic Act and conducted per Compliance Program 7348.004, focused on the analytical components of bioequivalence studies supporting two Abbreviated New Drug Applications (ANDAs). While no Form FDA-483 (List of Inspectional Observations) was issued, the inspection highlighted several areas requiring attention. A primary discussion point at the close-out meeting was the firm's failure to adequately evaluate the accuracy and precision of In Vitro Permeation Test (IVPT) quality control samples prepared with a placebo formulation, an aspect crucial for method validation. Mylan Pharmaceuticals committed to providing a written response to the FDA within 15 days addressing this issue. Other observations included discrepancies in solubility data between different testing facilities, unsubmitted validation study reports, and incomplete shipping documentation for investigational products. A significant procedural concern involved the co-mingling of retention samples, making individual shipment identification impossible. An affidavit was obtained confirming the representativeness of retained samples, and a test article sample was collected for further bioequivalence testing. These findings emphasize the need for robust documentation and adherence to method validation best practices to ensure data integrity and regulatory compliance.