Warning Letter Cites Valeant For Quality Systems Issues
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.
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