Warning Letter: Validation not documented (ucm489358)

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Ofni Systems

There is no change control procedure or documentation for moving from Computer Numeric Control process.

Failure to establish and maintain procedures for changes to a specification, process, or procedures, as required by 21 CFR 820.70(b). Specifically,

On or about 5/12/2014, you had your contract manufacturer change from using Computer Numeric Control process to a hydroforming process to manufacture the ONE TRAY. You have not established process change procedures nor has this change been documented and verified/validated.

Your November 10, 2015 response cannot be assessed at this time. Your response states that you will fully document the validation activities performed to support the new manufacturing process; and will update your agreement with the contract manufacturer to address process changes. Please provide an update on the progress of these corrective actions.

View the original warning letter.


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