17
Dec
2002

Eastern Medical Equipment Distributors Inc

0

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

FDA District: Florida District Office

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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