FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Validation, Procedures to Control Product Lax at IVD Lab

Nov. 6, 2019
A A

Procedures for accepting in-process product and procedures to control products that don’t conform to specifications were found to be lacking during an FDA inspection at Eurofins Viracor’s Lees Summit, Missouri, facility.

The diagnostic laboratory’s standard operating procedure didn’t include guidance for testing and retesting of nonconforming product during manufacturing of its Class II ImmuKnow immune cell function assays. Numerous acceptance records failed to pass quality control, but no retesting was conducted, the 483 said.

The FDA concluded that the firm’s procedures didn’t control nonconforming product. For example, definitions for severity and probability were not included in the SOP and certain high-risk variables didn’t require corrective and preventive actions.

View today's stories