Detention Without Physical Examination Of Medical Instruments from Pakistan

Reason for Alert

NOTE: The revision of this Import Alert dated 03/28/2024 updates the Guidance section, product description, and countries section. Changes are noted and bracketed with three asterisks (***). CDRH has determined that many steel medical instruments manufactured in Pakistan appear to be violative under section 501(c) of the Act, as the quality of the instruments appear to fall below that which they were represented to possess. Documented analysis revealed great variability in chromium content, causing concern that medical instruments manufactured in Pakistan are not compliant with the quality system regulations.

Product Description

Stainless steel or non-stainless steel medical instruments, whether for surgical use or have the potential for use in a surgical setting, whether indicated for surgical use or non-surgical use.

Charge

The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f) [Adulteration, Section 501(h)]. OASIS charge Code: DE IMP GMP

Guidance

Divisions may detain without physical examination all entries of medical instruments made of 100% steel, whether steel that is stainless or non-stainless; whether for surgical use or devices that have the potential for use in a surgical setting, whether indicated for surgical use or non-surgical use (e.g., Scissors, Forceps 21 CFR 878.4800);or whether intended for multiple use or disposable, from Pakistan, except those firms on the Green List of this Import Alert, unless specifically exempted by regulation (i.e. ring cutter 21 CFR 880.6200). Divisions should submit a recommendation to DIO, including analytical reports showing the failure of a lot, for detention without physical examination under this import alert of firms whose medical instruments have been sampled. DIO will forward the recommendation for removal from the green list to CDRH for consideration. CDRH will evaluate the recommendation and determine whether the evidence substantiates the green list removal recommendation on a case by case basis. Devices are manual, surgical instruments made of stainless steel or non-stainless steel, class I and are exempt from pre-market notification. These devices have the potential for use in a surgical setting, whether indicated for surgical use or non-surgical use (e.g., Scissors, Forceps 21 CFR 878.4800). Instruments include various types of forceps, scissors, hemostats, needle holders, etc. They are regulated under several program areas and product codes. In order for a firm to be exempt from detention without physical examination, documentation should be provided to FDA confirming that the manufacturing firm is operating in accordance with Quality System Regulations by a person knowledgeable in Quality System Regulations. The devices should be manufactured in accordance with the document entitled Adoption of GMP Regulations by The Manufacturers Of Surgical Instruments In Pakistan that was developed by The Surgical Instrument Manufacturers Association of Pakistan. 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. Audit results and supporting documents should be submitted to CDRH/OC at cdrhpakistaniaudit@fda.hhs.gov for review and approval. The 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: � List of the manufacturer's products � Advertising materials: catalogs, brochures, web page, etc. � 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): o Date o Type o 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 When FDA has been provided sufficient information to establish that a Pakistan instrument manufacturer is operating in compliance with the Quality System Regulation based on the audit report, the manufacturer will be exempted from Detention Without Physical Examination and placed on the Green List of this Import Alert. Re-inspection audit reports may periodically be requested for compliance to the Quality System Regulation. If there is a failure in the audit report, the firm can be removed from the Green List of this Import Alert. Removal from exemption is not supportable when the evidence is based on an analysis of medical instruments that have been stored, kitted or further processed outside the Pakistan manufacturing facility. Questions or issues involving import operations or the submissions of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov. Questions involving policy and/or sample collection recommendations, or any additional questions, should be addressed to CDRH at cdrhimport@fda.hhs.gov.

Affected Countries (1)