Depuy Orthopaedics, Inc.
FDA inspection history across 2 sites, 2004 to 2011
- 3
- EIRs
- 2
- Close-outs
- 2
- Warning letters
- 2
- Form 483s
Every document, by year
- Close-out
- Warning letter
- EIR
- Form 483
2004: one Form 483; 2008: two inspection reports and one Form 483; 2009: one inspection report; 2010: one close-out letter and one warning letter; 2011: one close-out letter and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2004One Form 483, at Warsaw, Indiana.
- 2008–11Three inspection reports, two close-out letters, two warning letters and one Form 483, at Warsaw, Indiana and Warsaw, Wisconsin.
- 2008The longest 483 on file: 1 observation over 2 pages at Warsaw, Wisconsin.
Cited most
Across all Depuy Orthopaedics observations on file
- 21 CFR 820.30Design controls2
The complete Depuy Orthopaedics file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Warsaw, Indiana
Three inspection reports, two warning letters and one Form 483 · 2004 to 2011 · 1 observation
Latest: Warning letter, Dec 8, 2011 →Warsaw, Wisconsin
One Form 483 · 2008 · 1 observation
Latest: Form 483, Jan 22, 2008 →
Also: two documents not tied to a site.
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2011-12-08 | Close-out Close-out letter | — | — | $99 |
| 2011-12-08 | Warning letter Warning letter | Warsaw, Indiana | — | $99 |
| 2010-08-19 | Close-out Close-out letter | — | — | $99 |
| 2010-08-19 | Warning letter Warning letter | Warsaw, Indiana | — | $99 |
| 2009-06-01 | EIR EIR | Warsaw, Indiana | — | $550 |
| 2008-01-28 | EIR EIR | Warsaw, Indiana | — | $550 |
| 2008-01-22 | EIR EIR | Warsaw, Indiana | — | $550 |
| 2008-01-22 | 483 Form 483 | Warsaw, Wisconsin | 1 | $99 |
| 2004-09-21 | 483 Form 483 | Warsaw, Indiana | 1 | $99 |
Investigators on these documents
Calvin K. Cook (2)Eric S. Pittman (1)Myra K. Casey (1)Robert G. Riff (1)
FEI number 1818910 · most recent document Dec 8, 2011
About Depuy Orthopaedics, Inc.
How many FDA Form 483s has Depuy Orthopaedics, Inc. received?
FDA Intel has 2 Form 483s on file for Depuy Orthopaedics, Inc.; the most recent is dated Jan 22, 2008.
When was Depuy Orthopaedics, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Depuy Orthopaedics, Inc. is an establishment inspection report (EIR) dated Jun 1, 2009, for the site in Warsaw, Indiana.
What did FDA cite at Depuy Orthopaedics, Inc.?
The regulations cited most in the observations on file for Depuy Orthopaedics, Inc. are 21 CFR 820.30 (Design controls), 2 times.
Has Depuy Orthopaedics, Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Depuy Orthopaedics, Inc.; the most recent is dated Dec 8, 2011.