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 that your temperature recording device, the vacuum gauge, and the pressure gauges for the manifold filler have ever been calibrated.

FDA District: Florida