California Devicemaker Cited for Vendor Management
The FDA slapped Carlsbad, California diagnostics maker New Life Diagnostics with a Form 483 for deficiencies in handling its vendors, including insufficient evaluations.
An agency inspection noted that the firm did not document the qualification of its suppliers and failed to evaluate all of them as required. The vendors included panel, antigen, microplate suppliers and service providers.
The company also failed to maintain an approved vendor list and had no agreement in place requiring suppliers to alert it to production or service changes.