Symmetry Medical USA Inc
Form 483 issued June 15, 2016 · Warsaw, Indiana
- Inspection
- Jun 1 – Jun 15, 2016
- Investigator
- Debara Reese
- Observations
- 3
- Pages
- 4
- FEI number
- 3004776227
In short: On June 15, 2016, FDA issued a Form 483 with 3 observations to Symmetry Medical USA Inc in Warsaw, Indiana (FEI 3004776227) after an inspection that ran Jun 1 – Jun 15, 2016. The investigator was Debara Reese. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
CAPA and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.90(a) (1×) · 820.75(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Products that do not conform to specifications…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Debara Reese
6 documents · 2015–2023
Cites 820.75(a) (process validation) more than any other section. Most of their documents are for sites in Indiana.
The firmSymmetry Medical USA Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Symmetry Medical USA Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Symmetry Medical USA Inc?
Debara Reese is named on this Form 483, for the inspection of Jun 1 – Jun 15, 2016. Each investigator has a profile showing what they cite most.
When was Symmetry Medical USA Inc inspected by FDA?
The inspection ran Jun 1 – Jun 15, 2016, and the Form 483 is dated June 15, 2016.
How do I get the full Form 483 for Symmetry Medical USA 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.