Zimmer Biomet, Inc.
Form 483 issued November 22, 2016 · Warsaw, Indiana
- Inspection
- Sep 12 – Nov 22, 2016
- Investigators
- Joseph R. Strelnik· Suyang Qin· Thomas A. Peter
- Observations
- 4
- Pages
- 58
- FEI number
- 1825034
In short: On November 22, 2016, FDA issued a Form 483 with 4 observations to Zimmer Biomet, Inc. in Warsaw, Indiana (FEI 1825034) after an inspection that ran Sep 12 – Nov 22, 2016. The investigators were Joseph R. Strelnik, Suyang Qin and Thomas A. Peter. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures to control environmental conditions have…
- 03
Procedures have not been adequately established to control product that does not…
- 04
Procedures for design control…
This inspection in context
Joseph R. Strelnik
13 documents · 2011–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Indiana.
The firmZimmer Biomet, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zimmer Biomet, Inc.?
FDA listed 4 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The opening words of each observation are shown on this page.
Who inspected Zimmer Biomet, Inc.?
Joseph R. Strelnik, Suyang Qin and Thomas A. Peter are named on this Form 483, for the inspection of Sep 12 – Nov 22, 2016. Each investigator has a profile showing what they cite most.
When was Zimmer Biomet, Inc. inspected by FDA?
The inspection ran Sep 12 – Nov 22, 2016, and the Form 483 is dated November 22, 2016.
How do I get the full Form 483 for Zimmer Biomet, 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.