Zimmer Biomet, Inc.
Form 483 issued April 24, 2018 · Warsaw, Indiana
- Inspection
- Apr 9 – Apr 24, 2018
- Investigators
- Benjamin Dastoli· Christina L. Bigham· Rosanna M. Goodrich
- Observations
- 11
- Pages
- 18
- FEI number
- 1825034
In short: On April 24, 2018, FDA issued a Form 483 with 11 observations to Zimmer Biomet, Inc. in Warsaw, Indiana (FEI 1825034) after an inspection that ran Apr 9 – Apr 24, 2018. The investigators were Benjamin Dastoli, Christina L. Bigham, Rosanna M. Goodrich and Thomas A. Peter. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
7 of 11 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for coITective and preventive action have not been adequately established. This is a repeat observation…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Risk analysis is…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Benjamin Dastoli
12 documents · 2009–2023
Cites 820.75 (process validation) more than any other section. Most of their documents are for sites in Ohio.
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 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zimmer Biomet, Inc.?
FDA listed 11 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Zimmer Biomet, Inc.?
Benjamin Dastoli, Christina L. Bigham, Rosanna M. Goodrich and Thomas A. Peter are named on this Form 483, for the inspection of Apr 9 – Apr 24, 2018. Each investigator has a profile showing what they cite most.
When was Zimmer Biomet, Inc. inspected by FDA?
The inspection ran Apr 9 – Apr 24, 2018, and the Form 483 is dated April 24, 2018.
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.