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发表于 2015-11-4 17:56:34
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以下是FDA官方说明
Import Alert 66-40
FDA Home Import Program Import Alerts Imports Alerts by Number Import Alert
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 66-40
Published Date: 10/30/2015
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
Reason for Alert:
*** Foreign inspections of pharmaceutical manufacturers are being performed. Detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).
Detention without physical examination may also be appropriate when FDA receives information concerning inspections conducted by foreign or other government authorities under a Memorandum of Understanding or other agreement that FDA concludes reveals conditions or practices warranting detention of either particular products or all products manufactured by a firm.
DWPE of such firms remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation to the responsible FDA Center. ***
Guidance:
*** Districts may detain, without physical sampling and analysis, the indicated drug products from the foreign processors noted in the Red List of this import alert.
Foreign processors listed on the Red List of this import alert who would like to request removal from that list should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing its corrective actions, accompanied by documentation. For guidance on removal from detention without physical examination, refer to FDA-s Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)." Information supporting removal should be sent to CDER's Office of Compliance, (HFD-300). *** |
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发表于 2015-11-4 06:17:40
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