07
Aug
2001

Southeastern Home Oxygen Service Inc.

0

Company: Southeastern Home Oxygen Service Inc.
Date: 8/7/01
Product: Medical Oxygen

You failed to assure the adequacy of your firm’s current computer distribution tracking system. Review of 2 lots selected at random for comparison of production records with computerized tracking information revealed inconsistencies in the number of oxygen cylinders filled with those distributed.

FDA District: Atlanta 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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