Zimmer revealed its receipt of the August 24 letter earlier this week, saying it doesn’t expect to take a material hit from resolving the issues flagged in the letter and that it doesn’t bar the company from selling any devices made at the plant.
The FDA inspected the North Campus facility in Warsaw just before Thanksgiving 2016, documenting numerous violations in a Form 483. The company’s lengthy reply that December detailed its actions in remediating the problem, noting that company-wide audits put in place after the $14 billion merger of Zimmer and Biomet had already turned up problems at the site. Zimmer said it cleaned house after the inspection, replacing five operations and quality executives as it sought to bring the facility back into compliance.
But a re-inspection last April resulted in another Form 483 and now a warning letter flagging “continuing, significant violations of the quality system regulations” found during the most recent inspections conducted from April 9 to April 24.
The letter flagged Zimmer Biomet for not being able to show that its process for corrective and preventive actions can ensure that the plant meets finished product specifications.
“We are concerned about your firm’s ability to verify the effectiveness of the corrective actions included in this CAPA, when errors are not being identified in your interim processes,” the agency wrote in the letter, which also cited validation and sterilization issues.
The federal safety watchdog’s inspectors also found that the plant lacked adequate training procedures.
“During the inspection, we observed five separate operations in which employees on the production line were not following production procedures adequately,” according to the letter.
The inspectors also found problems with the North Campus facility’s design validation processes, its handling of non-conformance reports and its CAPA implementation, according to the warning letter.