Viant AS&O Holdings, Llc – FDA 483, Oct 28, 2024

During an FDA inspection from October 22-28, 2024, Viant AS&O Holdings, LLC, a medical device establishment located at 68 Mill Lane Road, Brimfield, MA, received a Form FDA 483 with two observations. Robert J. Shanley, Director of Operations, was the recipient.

Observation 1 noted inadequate procedures for ensuring purchased products and services conform to specified requirements. Specifically, (b) (4) material (b) (4) was used in lots (b) (4) and (b) (4) of a (b) (4) Class III medical device. The firm did not 100% verify the material's identity beyond a (b) (4) visual inspection for (b) (4) and did not notify the customer of this discrepancy. A visual inspection for metal identification is not a validated or verified process approved by the customer, as required by supplier agreement PR120-009, Rev34, for rework/re-inspection/re-processing of nonconforming product.

Observation 2 identified inadequacies in procedures for incoming product acceptance. The Incoming Inspection document BRIM-WI-10-03 and (b) (4) Safety and Use Instructions document BRIM-WI-10-07 require documenting (b) (4) verification of equipment used for metal analysis at incoming inspection, using an