Telemetry Maker ScottCare Warned on GMP Violations

The FDA has handed telemetry maker ScottCare a warning letter for a host of GMP violations at its Cleveland, Ohio, plant, including improper implementation of corrective and preventive action (CAPA) procedures.

One major call out says ScottCare was not properly analyzing data on nonconforming product. For instance, 41 out of 157 complaints on the company’s TeleSentry device were attributed to a “bad SD Card.”

Unfortunately, ScottCare also did a poor job tracking complaints, the FDA said. Inspectors found several communications that met the criteria for a complaint filed as “non-complaints.”

Complaint management systems have long been an easy target for FDA inspectors, as seen with ScottCare. Come up short in an inspection and the FDA can declare your entire system “out of control” and issue a Form 483 or a warning letter.

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