Detention Without Physical Examination Of Medical Instruments from Pakistan

NOTE: The revision of this Import Alert dated 10/03/2011 updates the Guidance section and Reason for Alert section to reflect current Agency thinking regarding removal from detention without physical examination. Changes are noted and bracketed with three asterisks (***).


*** 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 firms 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. ***

*** Districts may detain without physical examination and analysis all entries of steel medical instruments, whether steel that is stainless or non-stainless; whether for surgical use or non-surgical use; or whether intended for multiple use or disposable, from Pakistan, except those firms on the Green List of this Import Alert.

Stainless steel and non-stainless steel instruments, either reusable or disposable, originating in Pakistan are subject to this import alert unless specifically exempted by regulation (i.e. ring cutter 21 CFR 880.6200).

***In order for a firm to be exempt from detention without physical examination, documentation should be provided to FDA confirming that the exporting firm is operating in accordance with Quality System Regulation, by a person knowledgeable in the Quality System Regulation. Such 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. The audit results and supporting documents are submitted to CDRH/OC for review and approval. 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.

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.

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.

Districts should submit a recommendation, 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.

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.

Third Party Audit Report

The 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 manufacturers 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

Anesthesiology
Dental
Gastroenterological & Urological
General Hospital/Personal Use
Obstetrical & Gynecological
Orthopedic
Radiological
Cardiovascular
Ear, Nose and Throat
General & Plastic Surgery
Neurological
Ophthalimic
Physical Medicine

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 requirements of section 520(f) [Adulteration, Section 501(h)].

OASIS charge code - DE IMP GMP