FDA sends warning letters to 12 medical device companies

The FDA today published the warning letters it sent recently to 12 medical device companies in the U.S. and overseas for violations found during recent inspections.

The federal safety watchdog’s inspectors found a variety of problems at the companies’ plants, ranging from inadequate design control procedures to problems with the way they track and report adverse events. The firms make a variety of products, including electro-surgical and laser surgery instruments, orthopedic implants, surgical drapes and gowns, teeth whitening devices, dental floss and compression socks:

• A.R.C.O.S., Brescia, Italy (compression socks) – 11 violations:
  1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met;
  2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  3. Failure to establish and maintain procedures to control product that does not conform to specified requirements;
  4. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications;
  5. Failure to establish and maintain procedures for acceptance activities;
  6. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures;
  7. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
  8. Failure to establish and maintain procedures for implementing corrective and preventive action;
  9. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system;
  10. Failure to establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics;
  11. Failure to develop, maintain, and implement written MDR procedures.
• Aussimed, Neuried, Germany (biofeedback devices) – 5 violations:
  1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met;
  2. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants;
  3. Failure to establish and maintain procedures for implementing corrective and preventive action;
  4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  5. Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit, are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR).
• Beyond Technology, Nanchang, China (teeth whitening devices & dental floss) – 3 violations:
  1. Failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality;
  2. Failure to establish and maintain procedures to control product that does not conform to specified requirements;
  3. Failure to establish and maintain procedures to control product that does not conform to specified requirements;
• C World KSG, Cavite, Philippines (contact lenses) – 4 violations:
  1. Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met;
  2. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA);
  3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  4. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.
• F.P. Rubinstein Y Cia, Cordoba, Argentina (laser-powered surgical instruments) – 15 violations:
  1. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA);
  2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  3. Failure to establish and maintain procedures for validating the device design;
  4. Failure to establish and maintain procedures for verifying the device design;
  5. Failure to ensure that where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures;
  6. Failure 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;
  7. Failure to establish and maintain procedures to control environmental conditions, where they could reasonably be expected to have an adverse effect on product quality;
  8. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
  9. Failure 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 is capable of producing valid results;
  10. Failure to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR 820 and the manufacturer’s established quality policy and objectives;
  11. Failure to maintain device history records (DHRs);
  12. Failure to classify the laser product;
  13. Failure to affix to each laser the Warning logotype label;
  14. Failure to submit Annual reports for each year;
  15. Failure to submit Product reports for the Starlight dermatology laser prior to introduction into U.S. commerce.
• Helica Instruments, Edinburgh, U.K. (electrosurgical cutting & coagulation device) – 12 violations:
  1. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements;
  2. Failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  3. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation;
  4. Failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications;
  5. Failure to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions;
  6. Failure establish and maintain adequate procedures for verifying the device design to confirm that the design output meets the design input requirements;
  7. Failure to establish and maintain adequate procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development;
  8. Failure to establish and maintain adequate procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient;
  9. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria;
  10. Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
  11. Failure to establish and maintain adequate procedures for implementing corrective and preventive action;
  12. Failure to develop, maintain and implement written MDR procedures.
• Implants International, Cleveland, U.K. (orthopedic implants) – 6 violations:
  1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action;
  2. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedures;
  3. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements;
  4. Failure to establish and maintain adequate procedures to ensure that the design input requirements are documented;
  5. Failure to adequately maintain device master records (DMRs);
  6. Failure to develop, maintain and implement written MDR procedures.
• Master & Frank Enterprises, Guangdong, China (surgical drapes & gowns) – 4 violations:
  1. Failure to establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met;
  2. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA);
  3. Failure to adequately establish and maintain procedures to ensure that the device design is correctly translated into production specifications;
  4. Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements.
• Mooncup, Brighton, U.K. (menstrual cups) – 3 violations:
  1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met;
  2. Failure to report to FDA no later than 30 calendar days after the day your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a serious injury;
  3. MDR procedure issues: a. Your firm’s MDR procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements; Your firm’s MDR procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part; Your firm’s MDR procedure does not establish internal systems that provide for timely transmission of complete MDRs; Your firm’s MDR procedure does not describe how it will address documentation and record-keeping requirements.
• Novastep, Saint-Gréoire, France (bone staples, screws, plates & intermedullary implants) – 5 violations:
  1. Failure to define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results;
  2. Failure to establish and maintain adequate procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications;
  3. Failure to establish and maintain adequate procedures to control all documents that are required by 21 CFR Part 820;
  4. Failure to report to FDA no later than 30 calendar days after the day that the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury;
  5. Failure to adequately develop, implement and maintain written MDR procedures.
• Spiegelberg, Hamburg, Germany (intercranial pressure monitoring products) – 8 violations:
  1. Failure to establish and maintain procedures for validating the device design;
  2. Failure to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product;
  3. Failure to establish and maintain procedures for implementing corrective and preventive action;
  4. Failure to ensure that when computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol;
  5. Failure to establish and maintain procedures to control product that does not conform to specified requirements;
  6. Failure to report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned, and this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;
  7. Failure to adequately develop, maintain, and implement written MDR procedures;
  8. Failure to submit a written report to FDA of any correction or removal of a device initiated to reduce a risk to health posed by the device.
• W&R Investments (dba Laser Engineering), Nashville (flexible CO2 laser waveguide) – 6 violations:
  1. Failure to establish and maintain procedures for validating the device design;
  2. Failure to establish and maintain processes for verifying the device design;
  3. Failure to maintain device history records;
  4. Failure to maintain a device master record;
  5. Failure to establish and maintain the requirements, including quality requirements that must be met by suppliers, contractors and consultants;
  6. Failure to establish and maintain procedures to control product that does not conform to specified requirements.

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