Depuy Orthopaedics, Inc.
Form 483 issued January 22, 2008 · Warsaw, Wisconsin
- Inspection
- Dec 3, 2007 – Jan 22, 2008
- Investigator
- Calvin K. Cook
- Observations
- 1
- Pages
- 2
- FEI number
- 1818910
In short: On January 22, 2008, FDA issued a Form 483 with 1 observation to Depuy Orthopaedics, Inc. in Warsaw, Wisconsin (FEI 1818910) after an inspection that ran Dec 3, 2007 – Jan 22, 2008. The investigator was Calvin K. Cook. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Design validation did not ensure that devices conform to defined user/patient…
This inspection in context
Calvin K. Cook
2 documents · 2008
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Indiana.
The firmDepuy Orthopaedics, Inc. history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Depuy Orthopaedics, Inc.?
FDA listed 1 observation on this Form 483, mostly about 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 Depuy Orthopaedics, Inc.?
Calvin K. Cook is named on this Form 483, for the inspection of Dec 3, 2007 – Jan 22, 2008. Each investigator has a profile showing what they cite most.
When was Depuy Orthopaedics, Inc. inspected by FDA?
The inspection ran Dec 3, 2007 – Jan 22, 2008, and the Form 483 is dated January 22, 2008.
How do I get the full Form 483 for Depuy Orthopaedics, 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.