Zimmer Inc.
Form 483 issued July 22, 2011 · Warsaw, Indiana
- Inspection
- Jul 6 – Jul 22, 2011
- Investigators
- Gary D. Urbiel Goldner· Sean T. Creighton· Thomas A. Peter
- Observations
- 10
- Pages
- 21
- FEI number
- 1000220733
In short: On July 22, 2011, FDA issued a Form 483 with 10 observations to Zimmer Inc. in Warsaw, Indiana (FEI 1000220733) after an inspection that ran Jul 6 – Jul 22, 2011. The investigators were Gary D. Urbiel Goldner, Sean T. Creighton and Thomas A. Peter. Most observations concern production & process controls and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Production & process controls and design controls account for 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action…
- 02
Design validation did not ensure the device conforms to defined user…
- 03
Procedures for design output…
- 04
Procedures for design input…
This inspection in context
Gary D. Urbiel Goldner
4 documents · 2008–2015
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Indiana.
The firmZimmer Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zimmer Inc.?
FDA listed 10 observations on this Form 483, mostly about production & process controls, design controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Zimmer Inc.?
Gary D. Urbiel Goldner, Sean T. Creighton and Thomas A. Peter are named on this Form 483, for the inspection of Jul 6 – Jul 22, 2011. Each investigator has a profile showing what they cite most.
When was Zimmer Inc. inspected by FDA?
The inspection ran Jul 6 – Jul 22, 2011, and the Form 483 is dated July 22, 2011.
How do I get the full Form 483 for Zimmer 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.