Andersen Products.

Andersen Products, Haw River, NC, June 28 (Atlanta). Deviations from the QS rule in the manufacture of sterile medical devices, such as nasogastric tubes, sump pumps/tubes, intestinal tubes and wound drainage tubes, included unvalidated equipment for testing Shirley Wound Drain vent filters; incomplete validation of the Packaging Aids Impulse Sealer, the laboratory autoclave and the Sterijet sterilization process; uninvestigated complaints regarding possible failure of products to meet specifications; complaint-handling procedures that did not define required evaluation, investigation and actions to be taken; a lack of documentation to show maintenance and humidity sensor calibration for the Herrtronic Herrmidifier; a lack of design changes procedures; and failure to monitor or test deionized water for microbiological and chemical quality. The water was used in the production of microbiological media, FDA said. The agency also termed the devices misbranded because the company failed to submit Medical Device Reporting information regarding a nasogastric tube and a Miller-Abbott type intestinal tube. Premarket submissions and export certificates will not be approved until the violations are corrected. FDA considered the firm's proposed corrective actions, submitted in a May 19 response, adequate. The plant was inspected April 19-29. AE, C-H, Design, Val