Advanced Medical Optics, Inc.
Form 483 issued June 25, 2007 · Santa Ana, California
- Inspection
- May 31 – Jun 8, 2007
- Investigators
- Jennifer M. Gogley· William S. Vitale
- Observations
- 7
- Pages
- 12
- FEI number
- 3003843509
In short: On June 25, 2007, FDA issued a Form 483 with 7 observations to Advanced Medical Optics, Inc. in Santa Ana, California (FEI 3003843509) after an inspection that ran May 31 – Jun 8, 2007. The investigators were Jennifer M. Gogley and William S. Vitale. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and design controls account for 6 of 7 observations.
Most cited: 21 CFR 820.30 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Not all data from quality data sources are analyzed to identify existing and potential causes of…
- 03
Corrective and preventive action procedures addressing implementation and recording of changes in methods and procedures to…
- 04
Design verification did not confirm that the design output meets…
This inspection in context
Jennifer M. Gogley
8 documents · 2007–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmAdvanced Medical Optics, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Medical Optics, Inc.?
FDA listed 7 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Advanced Medical Optics, Inc.?
Jennifer M. Gogley and William S. Vitale are named on this Form 483, for the inspection of May 31 – Jun 8, 2007. Each investigator has a profile showing what they cite most.
When was Advanced Medical Optics, Inc. inspected by FDA?
The inspection ran May 31 – Jun 8, 2007, and the Form 483 is dated June 25, 2007.
How do I get the full Form 483 for Advanced Medical Optics, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.