FDA Intel

Zimmer Inc.

Form 483 issued October 16, 2017 · Warsaw, Indiana

Inspection
Oct 2 – Oct 16, 2017
Investigators
Joseph R. Strelnik· Rosanna M. Goodrich· Suyang Qin
Observations
8
Pages
12
FEI number
1000220733

In short: On October 16, 2017, FDA issued a Form 483 with 8 observations to Zimmer Inc. in Warsaw, Indiana (FEI 1000220733) after an inspection that ran Oct 2 – Oct 16, 2017. The investigators were Joseph R. Strelnik, Rosanna M. Goodrich and Suyang Qin. Most observations concern cAPA and production & process controls.

At a glance

CAPA and production & process controls account for 8 of 8 observations.

CAPA4
Production & process controls4

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.100(a)

    Procedures for corrective and preventive action have…

  2. 02
    21 CFR 820.90(a)

    Procedures have not been adequately established to control product that does not…

  3. 03
    21 CFR 820.130

    Device packaging an d/or shipping containers are not designed an d constrncted to protect the device…

  4. 04
    21 CFR 820.75(b)

    Procedures for monitoring and control of process parameters for a validated process have not been adequately…

4 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

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 firm

Zimmer Inc. history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other 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 Inc.?

FDA listed 8 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.

Who inspected Zimmer Inc.?

Joseph R. Strelnik, Rosanna M. Goodrich and Suyang Qin are named on this Form 483, for the inspection of Oct 2 – Oct 16, 2017. Each investigator has a profile showing what they cite most.

When was Zimmer Inc. inspected by FDA?

The inspection ran Oct 2 – Oct 16, 2017, and the Form 483 is dated October 16, 2017.

How do I get the full Form 483 for Zimmer Inc.?

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