Devices

12 QS Violations in Ropack Inspection

David McFarland

— 2 min read
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A 1/18-1/21/16 FDA inspection at Ropack, Inc., Montreal, Canada, found 12 Quality System Regulation violations in the firm’s manufacturing of artificial saliva. Specific violations noted on an FDA-483 included: 

  •          failing to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedures;
  •          failing to establish and maintain procedures for changes to a specification, method, process, or procedure;
  •          failing to establish and maintain adequate procedures for implementing corrective and preventive action;
  •          failing to establish and maintain adequate procedures to control product that does not conform to specified requirements;
  •          failing to define the type and extent of control to be exercised over product, services, suppliers, contractors, and consultants, based on evaluation results;
  •          failing to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system;
  •          failing to establish and maintain adequate procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, and to include provisions for handling, preserving, and storing equipment so that its accuracy and fitness for use are maintained;
  •          failing to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and can produce valid results;
  •          failing to establish and maintain adequate calibration procedures including specific directions and limits for accuracy and precision;
  •          failing to establish and maintain adequate procedures for quality audits and to conduct such audits to assure that the quality system complies with established quality system requirements and to determine quality system effectiveness;
  •          failing to establish procedures to ensure that all personnel are trained to adequately perform their assigned responsibilities and that training needs are established, maintained, and documented; and
  •          failing to establish and maintain adequate procedures to control all documents that are required by regulations.

The firm’s responses to 10 of the observations were not adequate, while the adequacy of responses to two of the observations could not be determined.

The letter says that due to the seriousness of the violations, Ropack’s NeutraSal product is being detained without physical examination when it enters the U.S. For the detention to be lifted, FDA says, the company must correct the violations and pass a re-inspection. Ropack was told to take action to correct the violations and prevent their recurrence and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.

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