Devices

National Biological Has QS Violations

David McFarland

— 2 min read
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An FDA inspection at National Biological Corp., Beachwood, OH, found lack of conformity with the current good manufacturing practice requirements of the Quality System Regulations, according to a 7/11 Warning Letter. Specific violations noted on an FDA-483 included: 

  •          failing to validate a process whose results cannot be fully verified by subsequent inspection and test;
  •          failing to establish and maintain procedures that address the identification, documentation, evaluation, segregation, and disposition of nonconforming product;
  •         failing to establish and maintain procedures to assure that all complaints are reviewed and evaluated to determine whether an investigation is necessary;
  •          failing to establish and maintain procedures for analyzing processes, work operations, concessions, quality audits, service records, complaints, returned product, and other sources of quality problems, and employing statistical methodology, where appropriate, to detect recurring quality problems;
  •          failing to have a complete risk analysis;
  •          failing to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements;
  •          failing to document rework and reevaluation activities in the device history record; and
  •          failing to establish and maintain procedures to assure that equipment is routinely calibrated, inspected, checked, and maintained.

The letter says the firm’s responses to the inspection observations were inadequate or could not be assessed at this time.

FDA also determined that the company’s Hand Foot II UVB-138 phototherapy devices are misbranded because National failed or refused to furnish material or information respecting the device that is required by regulations on reports of corrections or removals of medical devices. Specifically, the letter says, the company failed to submit a report within 10 working days of initiating a correction or removal. The agency recommends that the company update its Correction and Removal procedures to meet regulatory requirements.

National was told to take prompt action to correct the violations and to respond with a list of specific steps taken since the inspection to correct the violations, with an explanation of how it will prevent those or similar violations from occurring again, with documentation of the corrections or corrective actions it has taken and a timetable for completion.

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