Advanced Medical Optics, Inc.

FDA inspection history in Santa Ana, California, 2007

1
Form 483

Every document, by year

  • Form 483

2007: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2007One Form 483, at Santa Ana, California.

Cited most

Across all Advanced Medical Optics observations on file

The complete Advanced Medical Optics file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2007-06-25483 Form 483$99

Investigators on these documents

Jennifer M. Gogley (1)William S. Vitale (1)

FEI number 3003843509 · most recent document Jun 25, 2007

About Advanced Medical Optics, Inc.

How many FDA Form 483s has Advanced Medical Optics, Inc. received?

FDA Intel has 1 Form 483 on file for Advanced Medical Optics, Inc.; the most recent is dated Jun 25, 2007.

When was Advanced Medical Optics, Inc. last inspected by FDA?

The most recent FDA inspection document on file for Advanced Medical Optics, Inc. is a Form 483 dated Jun 25, 2007, for the site in Santa Ana, California.

What did FDA cite at Advanced Medical Optics, Inc.?

The regulations cited most in the observations on file for Advanced Medical Optics, Inc. are 21 CFR 820.30 (Design controls), 3 times; 21 CFR 803.50 (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.100 (Corrective and preventive action), 1 time.