WARSAW — After visiting Zimmer Biomet, the Food and Drug Administration has released 11 observations, or objectionable conditions, found during visits in April.
The observations were listed in an FDA Form 483, which can be viewed here. Each of the items addressed are things that need to be brought into compliance. The FDA Form 483 does not provide a final determination of whether any condition is in violation. No further action by the FDA has been taken at this time.
The 11 observations are listed below. It was noted that eight of these observations were repeat observations from the FDA’s visit in 2016.
- Procedures for corrective and preventative action have not been adequately established.
- A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
- Risk analysis is inadequate.
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
- Procedures to control environmental conditions have not been adequately established.
- Procedures have not been established to control product that does not conform to specified requirements.
- Procedures for acceptance activities have not been adequately established.
- Procedures for training and identifying training needs have not been established
- Procedures for monitoring and control of process parameters for a validated process have not been adequately established.
- Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
- Procedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been adequately established.
A press release published on Zimmer Biomet’s website states, “At the conclusion of the inspection on April 24, 2018, the FDA issued a Form 483 with 11 inspectional observations. None of the observations identified a specific issue regarding the performance of any particular product and all products continue to be manufactured by the facility. Zimmer Biomet stands behind the safety of the products manufactured at the Warsaw North Campus.”
The release continues, “The company notes that this re-inspection occurred as it continues to execute against its approximately two-year quality remediation plan at the Warsaw North Campus. Zimmer Biomet believes that considerable progress has been made over the past year, but more work remains to be completed. The company takes the FDA’s observations very seriously and, as part of the ongoing two-year remediation effort, continues to work diligently with independent consultants to address both existing and new Form 483 observations.”