Devicemaker Gets a Form 483 for Lack of Quality Policies, Training

“No formal quality policy on hand.” That’s what FDA field investigators wrote in a Form 483 report after inspecting Precision Systems’ Natick, Mass., plant in May 2011. These investigators determined that at Precision, “the organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21CFR 820.”

These requirements aren’t new — they’ve been around since 1978. Yet the FDA issues dozens of 483s like this every year for devicemakers. Many are followed up by warning letters, which can mean a company must stop selling its device, plus the FDA won’t approve any new devices from the company until it closes out the warning letter.

Precision failed just about every category of the QSR by not having established procedures to investigate for nonconformities or corrective and preventive actions (CAPA), not keeping records crucial to CAPA and having no procedures for handling customer complaints or methods to determine whether an event was worthy of a medical device report. Even though the osmometers and cryoscopes Precision makes are low-risk, Class I devices, they’re still required to comply with QSR.

In fact, all medical device manufacturers must train personnel in QSR requirements and procedures. Precision fell short of this requirement, too: Observation 6 of the483 specifically states “Procedures for training and identifying training needs have not been adequately established” at Precision’s plant.

How can you guarantee your company won’t suffer the same fate? If Precision had been using FDAnews’ Quality System Training DVD, it might have passed this inspection with flying colors. You can, too, with the FDA’s own training video.

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