Endotec Gets 483 for Sterilization, Validation Shortcomings

Endotec was left holding a Form 483 after FDA investigators found shortcomings with the orthopedic devicemaker’s procedures for validating and revalidating medical implants. For example, the Orlando, Fla., facility’s procedures for sterilization revalidation require at least one microbiological performance qualification, the Sept. 7, 2011, form states.
The GMP Letter