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Warning Letter issued by USFDA to subsidiary of Zimmer Biomet Holdings Inc. for cGMP violations

Zimmer Biomet has received warning letter from USFDA for its North Campus manufacturing facility located in Warsaw Indiana due to current good manufacturing practice non-conformities of its quality system.

The Warsaw facility underwent inspections by USFDA first in 2016 and then in April 2018 both of which resulted in the issuance of form 483 by USFDA.

According to the warning letter following observations were cited:

The facility failed to establish and maintain procedures for verifying or validating the corrective and preventive action to ensure that the action is effective and does not adversely affect the finished device.

The facility failed to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test then the process needs to be validated with a high degree of assurance and approved according to established procedure

The facility failed to develop, conduct, control and monitor production processes which is essential to ensure conformity of a device to its specifications.

The company failed to establish and maintain design validation procedures required to ensure completion of risk analysis.

The facility to establish and maintain procedures to adequately control environmental conditions which is an integral part to ensure that product is of good quality.

The facility failed to establish and maintain procedures for implementing corrective and preventive actions, including requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product and other sources of quality data.

According to the company,” It has already provided written responses to FDA detailing the corrective actions underway to address the FDA’s observations and will be regularly be in communication with FDA regarding its quality remediation plan at the Warsaw facility.” Although the warning letter has acknowledged the quality remediation plan as well as actions taken by Zimmer Biomet, however The FDA has also proposed a regulatory meeting to be held with the company to discuss the corrective and preventive action plan.