483
Advanced Concept Innovations LLCFDA 483 - Advanced Concept Innovations LLC - August 17, 2017
Record Details
An FDA inspection of Advanced Concept Innovations, Llc, a medical device contract manufacturer in Lakeland, FL, revealed significant deficiencies in their quality system. Observations included inadequate process validation for clean rooms and sealing processes, insufficient procedures for purchasing and supplier management, and a lack of documented software validation activities for manufacturing and quality systems.
Open in Dashboard
ID · b79dc4cb-4d73-43cd-96d9-6fdc40a36290