Powers Medical Devices Cited for Supplier Evaluations
The FDA cited Powers Medical Devices in a form 483 for failing to implement its supplier evaluation or internal audit procedures.
The agency inspected the company’s Boca Raton, Fla., facility in late August and early September 2016, and found had not conducted a supplier audit for its contract manufacturer and contract engineering firm.
The company also failed to issue a supplier corrective action request to its contract manufacturer to investigate the cause of customer complaints regarding loose screws in its Pacifier Activated Lullaby (PAL) device. In addition, it did not ensure that its contract manufacturer implemented the quality system regulation regarding this issue.
In addition, the company failed to report that an updated user manual with additional warnings was sent to customers, or that a new warning label was affixed to PAL devices.
The agency also faulted Power Medical’s procedures for reviewing complaints. For example, one complaint cited cracks in the plastic housing of PAL units, which the company blamed on rough handling by the customer, without documenting evidence to that effect. The company did not issue a corrective and preventive action to investigate and resolve the cracking issue.
The Form 483 also said the company failed to implement its internal audit procedure or conduct any quality audits.
The FDA expects you to hold your suppliers, vendors and contractors in a state of control. You are responsible if an inspection turns up problems with materials or services you have outsourced. Get your supplier audit program in shape now with Supplier Auditing: A Four-Part Plan.