FDA Finds FMEA Violations at Gulf Medical Fiberoptics

Gulf Medical Fiberoptics failed to establish and maintain adequate procedures for validating the design of its fiber optic cables, according to a Form 483 FDA investigators wrote after a follow-up inspection in 2010.

The company was cited, in part, because it didn’t re-evaluate the Failure Modes and Effects Analysis (FMEA) for cables that was part of a plan for Corrective and Preventive Actions (CAPA) the company had given to the agency after an earlier inspection.

Design validation is one requirement of the Quality System Regulation and must include software validation and risk analysis. An FDA warning letter sent to Gulf in September notes that it didn’t document results of final acceptance testing for endoscopic cable connector fit.

Overlooking small items such as this can result in product failure, and that’s why FMEA is so critical. But your company can go beyond FMEA with even more effective risk management tools.

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