A company recently received this 483 observation:
….. There is no agreement with suppliers, contractors and consultants to notify you of changes in the product or service.
Specifically, my review of the Quality agreements with the firm’s suppliers, contractors and consultants revealed deficiencies with 2 of the 7 contracts I reviewed. The firm had not established Quality agreements with all of their critical suppliers.
For more observations pertaining to medical devices, see Issue 1054available today. It also has observations pertaining to manufacturing controls, laboratory controls and sterile manufacturing controls.