Zimmer Inc.
FDA inspection history in Warsaw, Indiana, 2011 to 2017
- 3
- Form 483s
Every document, by year
- Form 483
2011: one Form 483; 2015: one Form 483; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One Form 483, at Warsaw, Indiana.
- 2011The longest 483 on file: 10 observations over 21 pages at Warsaw, Indiana.
- 2015–17Two Form 483s, at Warsaw, Indiana.
Cited most
Across all Zimmer observations on file
- 21 CFR 820.30(c)Design controls5
- 21 CFR 820.100(a)Corrective and preventive action3
- 21 CFR 820.72(a)Inspection, measuring, and test equipment3
- 21 CFR 820.75(a)Process validation3
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2
The complete Zimmer file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Warsaw, Indiana
Three Form 483s · 2011 to 2017 · 28 observations
Latest: Form 483, Oct 16, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-10-16 | 483 Form 483 | Warsaw, Indiana | 8 | $99 |
| 2015-11-20 | 483 Form 483 | Warsaw, Indiana | 10 | $99 |
| 2011-07-22 | 483 Form 483 | Warsaw, Indiana | 10 | $99 |
Investigators on these documents
Suyang Qin (2)Thomas A. Peter (2)Rosanna M. Goodrich (1)Gary D. Urbiel Goldner (1)Sean T. Creighton (1)Sargum C. Sood (1)Joseph R. Strelnik (1)
FEI number 1000220733 · most recent document Oct 16, 2017
About Zimmer Inc.
How many FDA Form 483s has Zimmer Inc. received?
FDA Intel has 3 Form 483s on file for Zimmer Inc.; the most recent is dated Oct 16, 2017.
When was Zimmer Inc. last inspected by FDA?
The most recent FDA inspection document on file for Zimmer Inc. is a Form 483 dated Oct 16, 2017, for the site in Warsaw, Indiana.
What did FDA cite at Zimmer Inc.?
The regulations cited most in the observations on file for Zimmer Inc. are 21 CFR 820.30(c) (Design controls), 5 times; 21 CFR 820.100(a) (Corrective and preventive action), 3 times; 21 CFR 820.72(a) (Inspection, measuring, and test equipment), 3 times.