Endotec Gets 483 for Sterilization, Validation Shortcomings

April 27, 2012

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.

Even reduced microbiological performance qualification would typically include at least one fractional or half-cycle exposure, including load temperature and humidity measurements.

Endotec’s failure to meet its requirements landed the company a Form 483. Often, the next step can be a warning letter.

About 93 percent of FDA device warning letters fall into 5 categories: risk management, design control, supplier quality, QSR compliance and postmarket surveillance. We call them the “big five.”
If you need help addressing your big five woes, register today for the Ninth Annual Medical Device Quality Congress this May 16–18. This is one event you can’t afford to miss.

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