Company: Eastern Medical Equipment Distributors Inc.Product: Oxygen USP and Oxygen Analyzer Date: 12/17/2002 Failure to routinely calibrate mechanical and electronic equipment used in the transfilling of Oxygen USP or keep records of calibration according to a written program designed to assure proper performance as required by 21 CFR 211.68. For example, there was no documentation...Read More

Company: Eastern Medical Equipment Distributors Inc.Product: Oxygen USP and Oxygen Analyzer Date: 12/17/02 Failure to routinely calibrate mechanical and electronic equipment used in the transfilling of Oxygen USP or keep records of calibration according to a written program designed to assure proper performance as required by 21 CFR 211.68. For example, there was no documentation...Read More