Home > Newsletters > FDAnews Device Daily Bulletin > Calif. Kit & Infusion Company Warned for Design Control, QS Concerns
FDAnews Device Daily Bulletin
Nov. 7, 2012 | Vol. 9 No. 219
Calif. Kit & Infusion Company Warned for Design Control, QS Concerns
First Medical Source, a Laguna Beach, Calif., company that assembles pain management kits and distributes infusion supplies, received an FDA warning letter related to design control failures and other quality system violations. Inspectors from the FDA’s Los Angeles district office uncovered seven broad areas of concern, noting First Medical did not have adequate device design control procedures and was unable to provide records on design input, output and validation.
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