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# 8 Observations in Zimmer Biomet FDA-483
- URL: https://www.fdaweb.com/8-observations-in-zimmer-biomet-fda-483/
- Published: 2018-02-07T12:00:00.000Z
- Updated: 2026-09-14T23:20:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140708

FDA has released the FDA-483 issued following a 10/2-10/16/17 inspection at Zimmer Biomet’s manufacturing facility in Warsaw, IN. Specific observations were: 

- failing to adequately establish procedures for corrective and preventive action;
- failing to adequately establish procedures to control product that does not conform to specified requirements;
- failing to design and construct device packaging and/or shipping containers to protect the device from alteration or damage during processing, storage, handling, and distribution;
- failing to adequately establish procedures monitoring and control of process parameters for a validated process;
- failing to adequately validate software used as part of the quality system for its intended use according to an established protocol;
- failing to adequately establish procedures to ensure equipment is routinely calibrated;
- failing to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established; and
- failing to implement written Medical Device Reporting procedures.