AHA Hyperbarics USA Corp.April 8, 2019

FDA 483 - AHA Hyperbarics USA Corp. - April 08, 2019

Record Details

AURA Hyperbarics USA Corp., an initial importer and distributor in Freeport, NY, received a Form FDA 483 following an inspection. The inspection identified one observation related to inadequate documentation of equipment calibrations. Specifically, the firm was unable to provide a calibration certificate for a digital manometer.

Company: AHA Hyperbarics USA Corp.
Inspection Date: April 8, 2019
Product Type: Other
Office: Division of Human and Animal Food Operations - East I
Person: Andrew J. Garufi

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