Mylan Form 483 Notes Documentation Failures

Mylan Pharmaceuticals was handed a Form 483 after it failed to follow its own written procedures to document certain items on its qualification discrepancy reporting form and file them as part of the qualification protocol. The Morgantown, W.Va., facility also didn’t completely fill out training development forms. Some forms didn’t list the name of the trainer and lacked the signature of the supervisor, according to the Feb. 17, 2010, form.
Drug GMP Report