MOOG Medical Devices Group
Form 483 issued July 30, 2015 · Salt Lake City, Utah
- Inspection
- Jul 7 – Jul 30, 2015
- Investigators
- Amanda S. Zorn· Ashleigh P. Wodushek
- Observations
- 15
- Pages
- 20
- FEI number
- 1000117172
In short: On July 30, 2015, FDA issued a Form 483 with 15 observations to MOOG Medical Devices Group in Salt Lake City, Utah (FEI 1000117172) after an inspection that ran Jul 7 – Jul 30, 2015. The investigators were Amanda S. Zorn and Ashleigh P. Wodushek. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and production & process controls account for 10 of 15 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 03
Procedures or instructions for performing servicing activities have…
- 04
Design verification does not confirm that design output…
This inspection in context
Amanda S. Zorn
3 documents · 2014–2016
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Utah.
The firmMOOG Medical Devices Group history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MOOG Medical Devices Group?
FDA listed 15 observations on this Form 483, mostly about cAPA, production & process controls and design 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 MOOG Medical Devices Group?
Amanda S. Zorn and Ashleigh P. Wodushek are named on this Form 483, for the inspection of Jul 7 – Jul 30, 2015. Each investigator has a profile showing what they cite most.
When was MOOG Medical Devices Group inspected by FDA?
The inspection ran Jul 7 – Jul 30, 2015, and the Form 483 is dated July 30, 2015.
How do I get the full Form 483 for MOOG Medical Devices Group?
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.