The 58-page document came after the Agency performed a site inspection at the Zimmer Biomet facility from Sept. 12 to Nov. 22 last year, and included some repeat observations from an earlier 2014 inspection.
The full list of observations mentioned in the Form 483 include:
- Failure to adequately validate, given established procedures, a process whose results cannot fully be verified by subsequent inspection and testing.
- Failure to adequately establish procedures to control environmental conditions.
- Failure to adequately establish procedures to control products that do not conform to specified requirements.
- Failure to establish procedures for design control.
- Failure to establish procedures for corrective and preventive actions.
- Failure to establish adequate process control procedures which describe process controls necessary to ensure conformance to specifications.
- Failure to establish adequate procedures for monitoring and control of process parameters for validated processes.
- Failure to adequately establish procedures for receiving, reviewing and evaluating complaints by a formally designated unit.
- Failure to adequately establish procedures for acceptance activities.
- Buildings are not of suitable design to perform necessary operations.
- Sampling plans not based on valid statistical rationale.
- Failure to adequately establish procedures for rework of nonconforming products.
- Failure to adequately establish procedures to ensure all purchased or otherwise received product and services conform to specified requirements.
- Failure to adequately establish document control procedures.
In December, the company said it was taking the Form 483 “very seriously” and that it was in the process of preparing a written response to the observations. Zimmer Biomet said it would continue to communicate with the FDA “regarding the status of the corrective actions and remediation work.”
“Zimmer Biomet is committed to operating a first-rate quality management system across its global manufacturing network. While the company is taking the necessary steps to address certain regulatory compliance gaps at the legacy Biomet operation in Warsaw, it remains confident in the quality, safety and efficacy of all of its products. No patient safety concerns have been identified with any of the products manufactured at the site,” the company wrote in its response to the Form 483 filing.