483
Bridge to Life LtdFDA 483 - Bridge to Life Ltd - September 21, 2023
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Bridge to Life Ltd, a specification developer in Northbrook, IL, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed failures in complaint handling, including inadequate investigation and documentation of device-related complaints and MDR reportability. Additionally, the firm failed to conduct required internal quality audits and management reviews as established in its own procedures.
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ID · 69087a75-2e21-4817-bc4f-749bb471d65b