The QMN Weekly Bulletin

A recent inspection of Pro-Paks’ Middletown, Conn., plant found a lack of formal documentation for sterilization validation and re-validation processes for production of Lasik surgical kits. FDA investigators noted in a May 10, 2011, Form 483 that Pro-Paks lacked a sterilization validation study as well as a contract agreement between the company and its contract sterilizer.
The GMP Letter