FDA WARNING_LETTER - Swiss American Products, Inc. - September 04, 2008

On August 12-15, 19, 27, and September 4, 2008, the FDA inspected Swiss American Products, Inc. in Carrollton, Texas, which manufactures wound care products including Elta® Hydrovase Gel, Elta® Silver Antimicrobial Wound Gel, Elta® Wound Gel, Elta® Wound Cleanser, Elta® Impregnated Gauze, and Elta® Soft Gauze. The Elta® Silver Antimicrobial Wound Gel is a prescription and OTC device. The inspection found these devices adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods, facilities, or controls did not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. Failure to establish and maintain design input procedures for devices (21 CFR 820.30(c)), specifically for Elta® Silver Antimicrobial Wound Gel. 2. Failure to maintain a device design history file (21 CFR 820.30(j)), lacking documentation for Elta® Silver Antimicrobial Wound Gel's design plans, inputs, outputs, reviews, risk analysis, changes, verification, validation, and transfer. 3. Failure to establish and maintain adequate procedures for device design