Arizona Devicemaker Cited for Lack of Procedures

November 5, 2019

A Phoenix, Arizona device manufacturer was hit with a Form 483 by the FDA over multiple missing procedures at its facility.

Cpapnea Medical Supply failed to establish procedures for crucial tasks, such as addressing CAPAs, handling complaints and defining requirements for medical device reports, the agency found during its inspection.

Procedures for finished device acceptance, design control and acceptance activities for contract manufacturers were also not in place, the agency said.

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