Ophthalmic Company Gets Form 483 on Procedure, Validation Issues
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.
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
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