FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Hyperbaric Technologies Cited for Documentation Issues

April 15, 2019

Failure to document numerous activities including validation, corrective and preventive actions, process changes and others landed Hyperbaric Technologies a Form 483 following a Sept. 19-26, 2018, inspection of its Amsterdam, New York, manufacturing facility.

The manufacturer of hyperbaric chambers and mountain bags failed to document process validation activities and results such as the sealing process for its Gamow nylon hyperbaric bags.

The company was also missing documentation for corrective and preventive actions. It implemented design changes but didn’t document revised records, such as engineering drawings and a bill of materials, to show the changes were effective.

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