FDA 483 - Swiss American CDMO, LLC - September 04, 2008

An FDA inspection of Swiss American Products, Inc. in Carrollton, TX, a medical device manufacturer, revealed significant deficiencies in its quality system. The firm failed to establish and implement adequate design controls, process validation, document controls, and quality audit procedures for its Elta® Silver Gel Antimicrobial Wound Gel products. Additionally, issues were noted in equipment cleaning documentation and medical device reporting procedures.