FDA Sets Deadline for CSZ External Quality Audit

Citing unapproved changes and systemic failures ranging from nonconforming product to complaint handling, the FDA has asked Cincinnati Sub-Zero (CSZ) to have an external consultant audit its manufacturing and quality assurance systems. The company is to submit by Dec. 15 an initial audit with certification by its CEO that all the corrections called for in the report have been initiated or completed, according to a July 13 warning letter. Subsequent reports and certifications are due March 15 and June 15.
The GMP Letter