First Medical Source, a Laguna Beach, Calif., company that assembles pain management kits and distributes infusion supplies, has been warned for design control failures and other quality system violations.
First Medical’s corrective and preventive action (CAPA) procedures were found wanting, according to the Sept. 26 letter posted recently online.
A series of infusion pump leaks were investigated and noted as corrected, but the company did not maintain records validating the corrections. Its response to this observation in the post-inspection Form 483 was found inadequate because it did not document the verification or validation of corrective design changes, or a retrospective review of other verification and validation actions. In addition, the company’s CAPA records were missing details about investigations and follow-up.
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