If there is a failure in the audit report, the firm can be removed from the Green List of this Import Alert.

Re-inspection audit reports may periodically be requested for compliance to the Quality System Regulation. 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.Ĝurrent Audit Summary and Recommendations Quality System Review Elements:.Ğxternal Audit History for Previous Five Years (GMP, ISO, CE Mark, other): oĝate o Type o Summary of External Audit.Ědvertising materials: catalogs, brochures, web page, etc.Background Information and brief history of firm including: This should not be considered an all-inclusive list and additional information may be included. ***The Third-Party audit report should address, at a minimum, the applicable elements of the Quality System Regulation including the following information, as appropriate. Audit results and supporting documents should be submitted to CDRH/OC at for review and approval. ***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. Facebook gives people the power to share and makes the world. CDRH will evaluate the recommendation and determine whether the evidence substantiates the addition to DWPE recommendation on a case by case basis.*** 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. Join Facebook to connect with Riaz Miana and others you may know. DIO will forward the recommendation for addition to DWPE (removal from the green list) to CDRH for consideration. Divisions should submit a recommendation to the Division of Import Operations (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. Hussain, H., Aziz, S., Miana, G.A., Ahmad, V.U., Anwar, S., Ahmed, I. *** Divisions may detain without physical examination 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, unless specifically exempted by regulation (i.e.

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