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The QMN Weekly Bulletin
July 20, 2012 | Vol. 4 No. 29
California Devicemaker Warned By FDA on Numerous GMP Lapses
An optical supplies manufacturer has received an FDA warning letter for nine violations, including complaint handling, device design and corrective and preventive action (CAPA) failures.
The letter to American Optisurgical (AOI) from the FDA’s Los Angeles District Office is dated June 14 and follows a Jan. 30-Feb. 23 inspection of the company’s Lake Forest, Calif., plant.
AOI neglected to document that a device had been validated through testing in actual or simulated use conditions and failed to follow its design input procedure, making changes to a device without the approval of a design project manager. Steps that ensure design outputs are documented, reviewed and approved before devices go to market also were not met, the warning letter states. Design transfer procedures were inadequate, making it impossible to track the process of design changes between engineering and manufacturing, it adds.
AOI’s document control procedures did not require a signature to show that design changes and device history records had been approved, the FDA notes. Finally, software used in device manufacturing and testing was not validated.
Inspectors also faulted AOI’s CAPA procedures, saying they allow nonconforming product reports to be closed out “if a disposition decision is made to ‘scrap’ or accept product ‘as is,’” with little evaluation to determine if a CAPA is appropriate. Promised CAPA have not been implemented, according to the letter.
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