WARSAW — The Food and Drug Administration has issued a warning to the Montreal, Quebec, Canada, plant of Zimmer-Biomet Inc. pertaining to requirement nonconformities.
The Food and Drug Administration performed an inspection of the facility, ORTHOsoft Inc., earlier in May and completed the required Form 483 listing observations made during the inspection, including violations. It was not specified in the news release what these violations were.
The warning letter, received Tuesday, May 31, and dated Friday, May 27, points out these violations and states approval for “premarket approval applications for class III devices” will not be granted until the violations are corrected.
Zimmer-Biomet has since submitted a detailed response to the FDA outlining corrective actions it plans to take to address the issue.
At publication time, a message left at the Zimmer-Biomet, Warsaw, office had not been returned.
The following statement was included in a report issued by Zimmer-Biomet, disclosing the situation:
“The company takes these matters seriously and intends to respond fully and in a timely manner to the FDA’s warning letter. The company believes that the FDA’s concerns set forth in the warning letter can be resolved without a material impact to the company’s financial results. The company cannot, however, give any assurances that the FDA will be satisfied with its response to the warning letter or as to the expected date of the resolution of the matters included in the warning letter. Until the violations are corrected, the company may be subject to additional regulatory action by the FDA.”