UK Probe Maker’s Supplier Controls Fall Short

Berwickshire Electronic Manufacturing, a UK contract manufacturer, did not set requirements to evaluate suppliers and fell short on several other supplier control measures, according to an FDA warning letter.

Its purchasing procedure did not require records of acceptable suppliers, quality benchmarks that suppliers must meet, or documented agreements that suppliers will notify BEM of changes when possible.

Further, BEM had not set purchasing control requirements for certain suppliers of components for its Helica Thermal Coagulators and Helica LT/LTC Probes, according to the Feb. 4 letter posted June 21 on FDA’s website. Berwickshire lacked incoming product acceptance records for components, including parts that are manufactured and supplied according to specifications.