FDA update October 12, 2011

FDA Revises Import alert-Detention without physical examination of medical instruments from Pakistan

In 1991, FDA issued Import Alert 76-01 for stainless steel surgical instruments manufactured in Pakistan. The import alert provided guidance that the instruments appeared to be violative under section 501(c) of the Act, as the quality of the instruments appeared to fall below that which they were purported or represented to possess.

The import alert was put in place after documented analysis revealed great variability in chromium content, causing concern that medical instruments manufactured from Pakistan were not compliant with the quality system regulations.

FDA implemented a third party Quality System Audit Program to verify the compliance of manufacturers of medical instruments intended to be distributed within the United States. This third party auditor verification was coupled with sample analysis regimen to exempt firms from Detention Without Physical Examination.

FDA has recently reviewed this program, and now believes verification of firm’s compliance with the Quality System Regulation should be sufficient evidence to exempt a firm from Detention Without Physical Examination without any additional sampling regimen.

  • Firms will be placed on the Green List of this Import Alert after having a Quality System audit by a third party auditor which demonstrates there are no significant quality system deficiencies. The audit results and supporting documents should be submitted to CDRH/OC for review and approval.
  • Supporting documentation should include evidence of a complete review of all steps of the manufacturing process, including quality assurance, and traceability information from raw material to the finished device.
  • Re-inspection audit reports may periodically be requested for compliance to the Quality System Regulation.
  • Third Party Audit Report should address, at a minimum, the applicable elements of the Quality System Regulation including the following information, as appropriate. This should not be considered an all inclusive list and additional information may be included. Background Information and brief history of firm including:

a)    List of the manufacturers’ products Advertising materials: catalogs, brochures, web page,

b)    Certifications: ISO, CE Mark, etc. Facility address Number of Employees Number of shifts Chief Executive Officer Mailing Address Phone Fax E-mail External Audit History for Previous Five Years (GMP, ISO, CE Mark, other)

c)    Date Type Summary of External Audit Current Audit Summary and Recommendations Quality System Review Elements: Quality Manual Corrective Action Plan Device Master Record Device History Record Calibration Internal Audits External Audits Facilities Supplier Control Specifications Production Equipment Cleaning and Sanitation Personal Hygiene Training Hazardous Materials Handling Receiving, Storage, and Shipping Traceability and Recall Consumer Complaints/MDRs Pest Control

Conclusion:

FDA believes that verification of firms compliance with the Quality System Regulation should be sufficient for importation of medical instruments. The firm may then qualify for an exemption and be placed on the Green List of Import Alert 76-01.

For any questions on this FDA import alert please email us at info@mdiconsultants.com and Ref: Import Alert 76-01.

This is a good change for the FDA. But, companies require a work with a recognized third party consulting company. mdi has been working with companies in Pakistan for over 18 years providing guidance on FDA QSR compliance. If you would like more information on QSR compliance, please contact us. For more information on this import alert you can go to the following link: http://www.accessdata.fda.gov/cms_ia/importalert_224.html