Warning Letter: Failure to establish procedures (s6788c)

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Ofni Systems

Failure to establish design change control procedures for the identification, documentation, validation and/or verification, review, and approval of design changes before implementation. [21 CFR § 820.30(i)] Specifically, between 2003 and 2006, design changes were made to the Secure Safety Insert System. The molding operation was changed to improve the visibility of the biohazard symbol on the cap; the interlock of the cap into the tube was changed to improve the pull strength testing; and short caps were added to accommodate different size syringes.  Verifications and/or validations, design reviews, design releases, and design approvals were not performed for any of these changes.

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