FDA 483 - Jones Healthcare Group - Packaging Services, Inc. - November 18, 2022

An FDA inspection of Jones Healthcare Group - Packaging Services, Inc. in Brampton revealed significant deficiencies in their quality system, material handling, equipment management, and computer system controls. The firm, a contract manufacturer for packaging, failed to ensure proper procedure approval, material identity testing, equipment cleaning validation, appropriate equipment design, and computer system accuracy. These issues indicate a lack of robust controls necessary for drug product manufacturing and packaging.