Zimmer Biomet, Inc.
FDA inspection history across 2 sites, 2010 to 2018
- 2
- Close-outs
- 2
- Form 483s
- 1
- Response
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Response
- Warning letter
2010: one close-out letter and one warning letter; 2016: one Form 483; 2017: one 483 response; 2018: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One close-out letter and one warning letter, at Warsaw, Indiana.
- 2016–18Two Form 483s, one 483 response and one close-out letter, at Warsaw, Indiana and Indiana.
- 2018The longest 483 on file: 11 observations over 18 pages at Warsaw, Indiana.
Cited most
Across all Zimmer Biomet observations on file
- 21 CFR 820.70(a)Production and process controls3
- 21 CFR 820.75(a)Process validation3
- 21 CFR 820.30(a)Design controls2
- 21 CFR 820.90(a)Nonconforming product2
- 21 CFR 820.100(a)Corrective and preventive action1
The complete Zimmer Biomet file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Warsaw, Indiana
Two close-out letters, two Form 483s and one warning letter · 2010 to 2018 · 15 observations
Latest: Close-out, Aug 24, 2018 →Indiana
One 483 response · 2017
Latest: Response, Jul 11, 2017 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-08-24 | Close-out Close-out letter | Warsaw, Indiana | — | $99 |
| 2018-04-24 | 483 Form 483 | Warsaw, Indiana | 11 | $99 |
| 2017-07-11 | Response 483 response | Indiana | — | $199 |
| 2016-11-22 | 483 Form 483 | Warsaw, Indiana | 4 | $99 |
| 2010-07-27 | Close-out Close-out letter | Warsaw, Indiana | — | $99 |
| 2010-07-27 | Warning letter Warning letter | Warsaw, Indiana | — | $99 |
Investigators on these documents
Thomas A. Peter (2)Benjamin Dastoli (1)Christina L. Bigham (1)Joseph R. Strelnik (1)Rosanna M. Goodrich (1)Suyang Qin (1)
FEI number 1825034 · most recent document Aug 24, 2018
About Zimmer Biomet, Inc.
How many FDA Form 483s has Zimmer Biomet, Inc. received?
FDA Intel has 2 Form 483s on file for Zimmer Biomet, Inc.; the most recent is dated Apr 24, 2018.
When was Zimmer Biomet, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Zimmer Biomet, Inc. is a Form 483 dated Apr 24, 2018, for the site in Warsaw, Indiana.
What did FDA cite at Zimmer Biomet, Inc.?
The regulations cited most in the observations on file for Zimmer Biomet, Inc. are 21 CFR 820.70(a) (Production and process controls), 3 times; 21 CFR 820.75(a) (Process validation), 3 times; 21 CFR 820.30(a) (Design controls), 2 times.
Has Zimmer Biomet, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Zimmer Biomet, Inc.; the most recent is dated Jul 27, 2010.