Surgical Gown Maker Hit for Quality Letdowns

Failure to develop quality system practices such as process validations and procedures for accepting incoming product resulted in an FDA Form 483 for devicemaker Polyconversions following an inspection of its Champaign, Illinois plant.

The facility manufactures Poly Wear embossed gowns used in healthcare environments where there is the potential for contamination from bloodborne pathogens.

The inspection revealed that the equipment and the process used to seal the gowns were not validated to assure the gowns were fully sealed.