ZIMMER ORTHOPEDIC MFG LTD
Form 483 issued October 16, 2014 · Shannon, Ireland
- Inspection
- Oct 13 – Oct 16, 2014
- Investigator
- Ronald Ifraimov
- Observations
- 2
- Pages
- 3
- FEI number
- 3007963827
In short: On October 16, 2014, FDA issued a Form 483 with 2 observations to ZIMMER ORTHOPEDIC MFG LTD in Shannon, Ireland (FEI 3007963827) after an inspection that ran Oct 13 – Oct 16, 2014. The investigator was Ronald Ifraimov. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
CAPA and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.100(b) (1×) · 820.80(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results…
- 02
Procedures for acceptance of incoming product have…
This inspection in context
Ronald Ifraimov
10 documents · 2014–2026
Cites 820.30(b) (design controls) more than any other section. Most of their documents are for sites in Florida.
The firmZIMMER ORTHOPEDIC MFG LTD history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ZIMMER ORTHOPEDIC MFG LTD?
FDA listed 2 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected ZIMMER ORTHOPEDIC MFG LTD?
Ronald Ifraimov is named on this Form 483, for the inspection of Oct 13 – Oct 16, 2014. Each investigator has a profile showing what they cite most.
When was ZIMMER ORTHOPEDIC MFG LTD inspected by FDA?
The inspection ran Oct 13 – Oct 16, 2014, and the Form 483 is dated October 16, 2014.
How do I get the full Form 483 for ZIMMER ORTHOPEDIC MFG LTD?
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.