A high-precision compounding and dispensing device used to mix two solutions together received a warning letter following an inspection that revealed a failure to maintain procedures for validating the device design.

Valeant stated that clinical testing of the ONSET Mixing Pen product was conducted as part of the initial device design prior to the product being acquired by the firm, however, there was no documentation of previous validation testing and/or documentation supporting why the design validation was no longer relevant.

Additionally, the firm failed to establish and maintain procedures for the identification, documentation, validation or verification, review and approval of design changes before their implementation. The ONSET Mixing Pen, for which Valeant is a distributor, underwent a design change; but design change procedures did not assure that design validation activities occurred for the product.

Investigators also noted corrective and preventive actions surrounding field action for the ONSET Mixing Pen were incomplete. They did not address or document how their actions affected existing product in inventory.

The firm responded to all the allegations but the agency found them to be inadequate despite the firm saying it will revise design control SOP and believes the issues were an isolated incident.

Today’s minor mistake by your supplier could easily turn into tomorrow’s major recall. And if you don’t catch all the oversights in your quality agreement, odds are the FDA will. Use this 24-point plan to make sure you’ve covered all your bases and keep your suppliers well in hand. Order your copy of 24 Elements of a Successful Supplier Quality Agreement today.