Zimmer Biomet received a Form 483 from the FDA that cited eight issues following a 10-day in inspection in October 2017, according to RAPS.
The form explained Zimmer Biomet's failure to establish procedures for corrective and preventative actions. In the observation, the FDA specifically noted the company's usage of nonconforming Class 2 hip and Class 2 and 3 knee implants that were found sticking to its packaging.
Zimmer Biomet previously received a Form 483 following a December 2016 inspection.
Here are the eight cited failures, according to the FDA Form 483.
1. Procedures for collective and preventive action have not been adequately established.
2. Procedures have not been adequately established to control product that does not conform to specified requirements.
3. Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution.
4. Procedures for monitoring and control of process parameters for a validated process have not been adequately established.
5. Software used as part of the quality system has not been adequately validated for its intended use according to an established protocol.
6. Procedures to ensure equipment is routinely calibrated have not been adequately established.
7. Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
8. Written medical device reporting procedures have not been implemented.