Updated to include a response from Zimmer Biomet.
The FDA this week made public a Form 483 it sent to Zimmer Biomet (NYSE:ZBH) over issues it found during an inspection of its Warsaw, Ind.-based plant last year, laying out eight observations it determined need correction at the facility.
The federal watchdog released a 12-page document covering the issues it found during the inspection, which took place between Oct. 2, 2017 and Oct. 16, 2017, a number of which were repeat issues that the agency had previously noted during prior inspections.
The full list of observations made in the Form 483 include:
- Failure to adequately establish procedures for corrective and preventive action for nonconforming products (a repeat observation the FDA noted having seen during 2011, 2012, 2013, 2014 and 2015 inspections).
- Failure to adequately establish procedures to control product that does not conform to specified requirements.
- Failure to create device packaging or shipping containers designed and constructed to proceed the device from alteration or damage during processing, storage, handling and distribution (a repeat observation previously noted during a 2015 inspection).
- Failure to adequately establish procedures for monitoring and control of process parameters for a validated process.
- Failure to adequately validate quality system software for its intended use according to an established protocol.
- Failure to adequately establish procedures to ensure equipment is routinely calibrated (a repeat observation previously noted during a 2015 inspection).
- Failure to adequately establish procedures for receiving, reviewing and evaluating complaints by a formally designated unit (a repeat observation previously noted during a 2015 inspection).
- Failure to implement written MDR procedures (a repeat observation previously noted during a 2015 inspection).
Zimmer Biomet responded to the Form 483, saying it had responded appropriately to the FDA and was taking the necessary steps to address the cited issues.
“Like all medical device companies, Zimmer Biomet is subject to periodic FDA inspections. In the fourth quarter of 2017, the FDA completed an inspection of the legacy Zimmer manufacturing site in Warsaw, Indiana. As is often the case, at the conclusion of the inspection, the FDA issued various inspectional observations on Form 483. Zimmer Biomet takes the FDA matters very seriously and has submitted its written response to the Form 483 observations. The company has developed and is executing a remediation plan to fully address the issues cited by the FDA. The company will 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, it remains confident in the quality, safety and efficacy of all of its products,” Zimmer Biomet stated in response.
Last January, Zimmer Biomet received a similar Form 483 from the FDA after an inspection of its Warsaw, Ind.-based facilities which 14 observations made during its inspection.
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