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Home > Newsletters > The GMP Letter > Ophthalmic Company Gets Form 483 on Procedure, Validation Issues

The GMP Letter

October 2012

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.

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