FDA Intel

Zimmer Inc.

Form 483 issued November 20, 2015 · Warsaw, Indiana

Inspection
Oct 19 – Nov 20, 2015
Investigators
Sargum C. Sood· Suyang Qin· Thomas A. Peter
Observations
10
Pages
14
FEI number
1000220733

In short: On November 20, 2015, FDA issued a Form 483 with 10 observations to Zimmer Inc. in Warsaw, Indiana (FEI 1000220733) after an inspection that ran Oct 19 – Nov 20, 2015. The investigators were Sargum C. Sood, Suyang Qin and Thomas A. Peter. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).

At a glance

Production & process controls and capa account for 8 of 10 observations.

Production & process controls4
CAPA4
Design controls2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.250(b)

    Sampling plans are not based on valid statistical rationale . Note: This is a repeat from…

  2. 02
    21 CFR 820.100(a)

    Procedures for corrective and preventive action have not been adequately established. Note; This is a repeat…

  3. 03
    21 CFR 820.90(a)

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

  4. 04
    21 CFR 820.75(a)

    A process whose results cannot be fully verified by subsequent inspection and test has not been…

6 more observations

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

Get the full 483

This inspection in context

The investigator

Sargum C. Sood

5 documents · 2015–2017

Cites 820.30(d) (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 820.250(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Zimmer Inc.?

FDA listed 10 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.

Who inspected Zimmer Inc.?

Sargum C. Sood, Suyang Qin and Thomas A. Peter are named on this Form 483, for the inspection of Oct 19 – Nov 20, 2015. Each investigator has a profile showing what they cite most.

When was Zimmer Inc. inspected by FDA?

The inspection ran Oct 19 – Nov 20, 2015, and the Form 483 is dated November 20, 2015.

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

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