Warning Letter: Failure to establish procedures (ucm279180)

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Ofni Systems

Failure to establish and maintain adequate procedures for the identification, documentation, validation, or where appropriate, verification, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example: the device design was revised to include an [redacted] for both the ActiveCare DVT and ActiveCare+SFT devices. Your firm’s design validation report No.71365539, Safety Technical Report OVP, includes design verification test results where the device was tested at [redacted] but does not appear to include testing of production units under actual or simulated conditions as indicated in your Design Verification and Validation procedure referenced in your Design Changes Procedure.

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