> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 14 Observations in Zimmer Biomet Inspection
- URL: https://www.fdaweb.com/14-observations-in-zimmer-biomet-inspection/
- Published: 2017-01-19T12:00:00.000Z
- Updated: 2026-09-14T22:01:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137778

A 10-week FDA inspection at Zimmer Biomet from 9/12/16 to 11/22/16 led to a 58-page [FDA-483](http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm537137.pdf?ref=fdaweb.com) detailing 14 inspection observations, some of which were repeated from earlier inspections. The just-released document shows these violations: 

- failing to adequately validate according to established procedures a process whose results cannot be fully verified by subsequent inspection and test, repeated from a 2014 inspection;
- failing to adequately establish procedures to control environmental conditions;
- failing to adequately establish procedures to control product that does not conform to specified requirements;
- failing to establish procedures for design control;
- failing to adequately establish procedures for corrective and preventive action;
- failing to adequately establish process control procedures that describe any process controls necessary to ensure conformance to specifications;
- failing to adequately establish procedures for monitoring and control of process parameters for a validated process, repeated from a 2014 inspection;
- failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to adequately establish procedures for acceptance activities;
- failing to have buildings of suitable design to perform necessary operations;
- failing to have sampling plans based on valid statistical rationale;
- failing to adequately establish procedures for rework of nonconforming product;
- failing to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements; and
- failing to adequately establish document control procedures.

 The document says the company promised to correct all of the observations.