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Ophthalmic Company Gets Form 483 on Procedure, Validation Issues

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American Optisurgical, an ophthalmic device company based in Lake Forest, Calif., received a 13-observation Form 483 after an inspection by Irvine, Calif., CDRH staff stretching from Jan. 30 to Feb. 23.

The devicemaker lacked procedures defining the responsibility for review, and establishing authority for the disposition of nonconforming products, according to the FDA’s Form 483.

Additionally there were insufficient procedures for receiving, reviewing and for evaluating complaints by a formerly designated unit.

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