Warning Letter: Failure to establish procedures (ucm279058)

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Ofni Systems

Failure to establish and maintain 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).

Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example: Your firm does not have a purchasing control procedure and has not evaluated the contract manufacturer to ensure that manufacturing processes are appropriately validated. In addition, there are no maintenance procedures in place, nor has your firm established procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

View the original warning letter.


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