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Home » Ophthalmic Company Gets Form 483 on Procedure, Validation Issues
Ophthalmic Company Gets Form 483 on Procedure, Validation Issues
October 4, 2012
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 that stretched from Jan. 30 to Feb. 23.