Symmetry Medical Ireland Limited
Form 483 issued August 21, 2014 · Midleton, Ireland
- Inspection
- Aug 18 – Aug 21, 2014
- Investigator
- Cheryl D. McCall
- Observations
- 1
- Pages
- 2
- FEI number
- 3009813841
In short: On August 21, 2014, FDA issued a Form 483 with 1 observation to Symmetry Medical Ireland Limited in Midleton, Ireland (FEI 3009813841) after an inspection that ran Aug 18 – Aug 21, 2014. The investigator was Cheryl D. McCall. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Cheryl D. McCall
1 document · 2014
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Ireland.
The firmSymmetry Medical Ireland Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Symmetry Medical Ireland Limited?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Symmetry Medical Ireland Limited?
Cheryl D. McCall is named on this Form 483, for the inspection of Aug 18 – Aug 21, 2014. Each investigator has a profile showing what they cite most.
When was Symmetry Medical Ireland Limited inspected by FDA?
The inspection ran Aug 18 – Aug 21, 2014, and the Form 483 is dated August 21, 2014.
How do I get the full Form 483 for Symmetry Medical Ireland Limited?
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.