Devices

QS Violations Cited at Greek Device Maker

David McFarland

— 1 min read
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A 10/5-10/8/15 FDA inspection at DMP Ltd., Markopoulo, Greece, which manufactures dental impression materials and composite resins, found multiple Quality System Regulation violations, according to a just-released 3/4 Warning Letter. Specific violations listed on an FDA-483 included:

    • failing to establish and maintain procedures for implementing corrective and preventive actions;
    • 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 to ensure that all inspection, measuring, and test equipment including mechanical, automated, or electronic inspection and test equipment is suitable for its intended purpose and is capable of producing valid results;
    • failing to establish and maintain procedures for verifying the device design;
    • failing to establish and maintain procedures for validating the device design;
    • failing to establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics;
    • failing to establish and maintain procedures to ensure formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development;
    • failing to establish and maintain procedures to ensure that design requirements relating to a device are appropriate and address the intended use of a device, including the needs of the patient;
    • failing to establish and maintain procedures for quality audits and to conduct such audits to assure that the quality system complies with the established quality system requirements and to determine quality system effectiveness; and
    • failing to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and regulations.
The letter says that the company’s responses to all the observations were not adequate. 

DMP was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, documentation of each step, and a timetable for completion.

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