483
The Hygenic Company LLC.The Hygenic Company LLC. – FDA 483, Dec 17, 2021
Record Details
The Hygenic Company LLC, a manufacturer located in Akron, OH, received a Form FDA 483 with two observations. The inspection revealed that the firm failed to adequately establish procedures for the acceptance of incoming products and did not maintain adequate records for acceptable contractors, specifically concerning equipment calibration services. These findings indicate deficiencies in the firm's quality system controls.
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ID · f6f9c988-a71e-4ec1-9e24-34ca933defde
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