FDAnews Device Daily Bulletin

FDA Cites Peter Schiff on Validation Procedures, Record-Keeping

July 24, 2017

The FDA issued a Form 483 to Peter Schiff Enterprises, citing validation issues, incomplete records and inadequate procedures.

The agency issued the form after an April inspection of the devicemaker’s Cookeville, Tenn., facility, during which investigators found that the company had not validated its sterilization process for its adult or pediatric electrode pads. The facility also did not maintain proper device history records for those devices. The records on file did not include the location of the label and labeling for each product lot or batch, according to the form.

The device history records also did not include full information on examination and release of labeling, including the date and the examiner’s signature. The firm also had not established an adequate plan for corrective and preventive actions, instead relying on a document that provided a rough outline for recording CAPA activities.