483
Bleep, LLCBleep, LLC – FDA 483, Aug 6, 2026
Record Details
Bleep, LLC, a medical device manufacturer in Chapel Hill, NC, was cited for inadequate record-keeping related to risk management activities for a Class II medical device. The inspection revealed incomplete risk analysis worksheets and inconsistent hazard classifications, indicating a lack of thorough assessment. This suggests potential issues with the firm's quality system regarding product realization and risk control.
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ID · 4ffadbfd-7a82-4110-8f5c-880a8a3a4b68
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