FDA 483 - TT Electronics - June 29, 2026
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TT Electronics, a contract medical device manufacturer in Perry, OH, was cited for significant deficiencies in its quality system. Observations included inadequate documentation of risk management processes, a failure to apply a risk-based approach to the quality management system using post-market data, and insufficient documentation for infrastructure maintenance activities. Additionally, the firm failed to adequately maintain records of corrective actions, including a deleted corrective action for an assembly issue.
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