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. The 483 took American Optisurgical to task for several issues involving product design, including a lack of documentation of design process, design input, design transfer and design output procedures.
The GMP Letter