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.
The letter cites a host of other problems with procedures, noting the procedure for final inspection of probes did not ensure finished devices are quarantined or adequately controlled until their release. The agency said it would not allow the firm’s devices entry into the U.S. until violations are corrected.
BEM’s procedure for controlling nonconforming product did not properly address identification, documentation, evaluation, segregation and disposition. One employee told the inspector that the firm doesn’t document nonconformities identified during manufacturing operations and related activities for the Helica Thermal Coagulators and Helica LT/LTC Probes, the letter says.
It also cited Berwickshire for not establishing production and process control procedures, such as:
Meanwhile, the procedure to control monitoring and measuring devices did not include:
The letter points out that equipment used in final acceptance testing for some Helica Thermal Coagulators was out of calibration.
Another citation notes the corrective and preventive action procedures lacked key provisions, including requirements to use statistical methodology, when necessary, to detect recurring quality problems. BEM had not conducted and documented analyses of quality data at the time of the inspection. The firm’s CAPA also was not validated to ensure that corrective actions were effective and didn’t adversely affect the finished device.
The firm also was cited for failing to maintain device master records.
In addition to the GMP violations, the company has not fulfilled its annual registration requirements, making all of its products misbranded, the letter says.
The company did not respond to a request for comment by press time. The warning letter is available at www.fdanews.com/06-24-16-BEMWL.pdf. — April Hollis