Kent Elastomer Products IncOctober 16, 2025

FDA 483 - Kent Elastomer Products Inc - October 16, 2025

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Record Details

Kent Elastomer Products Inc, a contract medical device manufacturer in Kent, OH, received a Form FDA-483 with three observations. The inspection revealed inadequately established procedures for corrective and preventive actions (CAPA), supplier selection and assessment, and process validation. These findings highlight significant deficiencies in the firm's quality system documentation and implementation.

Company: Kent Elastomer Products Inc
Inspection Date: October 16, 2025
Product Type: Device
Office: Cincinnati District Office
Person: Laureen M. Geniusz (Investigator )

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ID · 8bc94c5f-79a8-4d39-8d4d-4515ca6791ff