FDA 483 - Oakworks Inc - January 17, 2024
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Oakworks Inc, a manufacturer of Class II imaging and pain management tables in New Freedom, PA, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's quality system, including inadequate design validation and verification, ineffective corrective and preventive actions, and poorly maintained complaint files. Additionally, the firm failed to conduct timely management reviews and ensure auditor independence, indicating systemic issues in quality management.
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