%PDF-1.3 1 0 obj << /Type /Catalog /Outlines 2 0 R /Pages 3 0 R >> endobj 2 0 obj << /Type /Outlines /Count 0 >> endobj 3 0 obj << /Type /Pages /Kids [6 0 R 21 0 R 33 0 R ] /Count 3 /Resources << /ProcSet 4 0 R /Font << /F1 8 0 R /F2 9 0 R /F3 10 0 R /F4 11 0 R >> /XObject << /I1 12 0 R /I2 13 0 R /I3 20 0 R >> >> /MediaBox [0.000 0.000 595.280 841.890] >> endobj 4 0 obj [/PDF /Text /ImageC ] endobj 5 0 obj << /Creator (DOMPDF) /CreationDate (D:20220609110014-04'00') /ModDate (D:20220609110014-04'00') /Title (Ventilators Dumped in Miami - BLOG) >> endobj 6 0 obj << /Type /Page /Parent 3 0 R /Annots [ 14 0 R 16 0 R 18 0 R ] /Contents 7 0 R >> endobj 7 0 obj << /Length 6690 >> stream 1.000 1.000 1.000 rg 34.016 34.016 527.249 773.859 re f q 441.000 0 0 97.500 45.016 710.374 cm /I2 Do Q 0.000 0.000 0.000 rg BT 45.016 699.385 Td /F1 9.0 Tf [(Published on )] TJ ET BT 99.547 699.385 Td /F2 9.0 Tf [(IVT Network)] TJ ET BT 149.056 699.385 Td /F1 9.0 Tf [( \()] TJ ET BT 154.555 699.385 Td /F1 9.0 Tf [(http://www.ivtnetwork.com)] TJ ET 0.000 0.000 0.000 RG 0.18 w 0 J [ ] 0 d 154.555 698.234 m 259.081 698.234 l S BT 259.081 699.385 Td /F1 9.0 Tf [(\))] TJ ET 0.620 0.620 0.620 rg 45.016 686.888 506.159 0.750 re f 0.000 0.000 0.000 rg BT 45.016 662.142 Td /F3 15.0 Tf [(Ventilators Dumped in Miami - BLOG)] TJ ET q 45.016 610.283 506.159 33.750 re W n 0.800 0.800 0.800 rg 45.016 643.658 13.005 0.750 re f 0.000 0.000 0.000 rg BT 45.016 623.669 Td /F1 9.0 Tf [(By)] TJ ET 0.800 0.800 0.800 rg 58.021 643.658 81.531 0.750 re f 0.000 0.000 0.000 rg BT 58.021 625.544 Td /F4 9.0 Tf [(Vladimir Gostuski)] TJ ET 0.800 0.800 0.800 rg 139.552 643.658 111.555 0.750 re f 0.000 0.000 0.000 rg BT 139.552 625.544 Td /F4 9.0 Tf [(May 26, 2021 7:00 am EDT)] TJ ET Q BT 45.016 499.544 Td /F1 9.0 Tf [(Recently, Miamis Local 10 news did a report on a large quantity of brand-new, still packaged, mechanical ventilators being )] TJ ET BT 45.016 485.808 Td /F1 9.0 Tf [(dumped in a landfill)] TJ ET BT 127.555 485.808 Td /F1 9.0 Tf [(. According to Local 10, the ACM812A ventilators manufactured by Beijing Aerospace Changfeng Ltd )] TJ ET BT 45.016 472.072 Td /F1 9.0 Tf [(were brought into the U.S. during the Spring of 2020 by an unidentified entity. The ventilators had to be either destroyed or )] TJ ET BT 45.016 458.336 Td /F1 9.0 Tf [(taken outside of the country because they were not on the FDAs list of ventilators under Emergency Use Authorization \(EUA\) )] TJ ET BT 45.016 444.599 Td /F1 9.0 Tf [(for the COVID-19 pandemic. On a follow-up of the story)] TJ ET BT 271.114 444.599 Td /F1 9.0 Tf [(, Local 10 posted an FDA Import Refusal Report dated Oct. 29th, )] TJ ET BT 45.016 430.863 Td /F1 9.0 Tf [(2020 stating Misbranding as the reason the FDA did not allow the entry of the ventilators. The FDAs online resources can be )] TJ ET BT 45.016 417.127 Td /F1 9.0 Tf [(navigated to fact-check Local 10s coverage.)] TJ ET BT 45.016 394.391 Td /F1 9.0 Tf [(The FDA defines an Import Refusal as FDAs final decision that a detained shipment is in violation of FDA laws and )] TJ ET BT 45.016 380.654 Td /F1 9.0 Tf [(regulations. A refused shipment must either be destroyed or exported under the supervision of Customs and Border Protection )] TJ ET BT 45.016 366.918 Td /F1 9.0 Tf [(\(CBP\) and FDA within 90 days of the date of the Notice of FDA Action \(Refusal Notice\))] TJ ET BT 398.158 366.918 Td /F1 9.0 Tf [(. The Import Refusal Report \(IRR\) )] TJ ET BT 45.016 353.182 Td /F1 9.0 Tf [(posted by Local 10 can be found by navigating to the FDAs IRR database search)] TJ ET BT 374.695 353.182 Td /F1 9.0 Tf [(, selecting Product, October in the month )] TJ ET BT 45.016 339.446 Td /F1 9.0 Tf [(field, 2020 for the year, and finally 73-Anestheseology for the product category. After a short scroll, four entries for BEIJING )] TJ ET BT 45.016 325.709 Td /F1 9.0 Tf [(AEROSPACE CHANGFENG CO., can be found. The reports list Product Code as 73CBK, FDA Product Description as )] TJ ET BT 45.016 311.973 Td /F1 9.0 Tf [(VENTILATOR, CONTINUOUS \(RESPIRATOR\), Refusal Date 29-Oct-2020, and FDA District as DNEI. The charges for )] TJ ET BT 45.016 298.237 Td /F1 9.0 Tf [(the IRR are Violation code NO 510\(K\), Section 801\(a\)\(3\); 502\(o\) Misbranding, Charge Statement The article is subject to )] TJ ET BT 45.016 284.501 Td /F1 9.0 Tf [(refusal of admission pursuant to Section 801\(a\)\(3\) in that it appears to be a post 1976 device for which a Section 510\(k\) )] TJ ET BT 45.016 270.764 Td /F1 9.0 Tf [(application has not been determined substantially equivalent or a 510\(k\) has not been filed.)] TJ ET BT 45.016 248.028 Td /F1 9.0 Tf [(From this information it is hard to determine if the ventilators in the IRR are the same as the ones being dumped in Miami. The )] TJ ET BT 45.016 234.292 Td /F1 9.0 Tf [(IRR does not state the device model, and the Beijing Aerospace Changfeng Ltd website shows three ventilators with differing )] TJ ET BT 45.016 220.556 Td /F1 9.0 Tf [(specifications and accessories under the ACM812A model. The refusal date is Oct. 29th, 2020, and the ventilators were )] TJ ET BT 45.016 206.819 Td /F1 9.0 Tf [(supposedly dumped in April 2021, far from the 90-day deadline. Also, the listed FDA district corresponds to the Division of )] TJ ET BT 45.016 193.083 Td /F1 9.0 Tf [(Northeast Imports \(DNEI\), and Florida corresponds to the Division of Southeastern Imports \(DSEI\).)] TJ ET BT 45.016 170.347 Td /F1 9.0 Tf [(The FDA Detention & Hearing webpage)] TJ ET BT 208.591 170.347 Td /F1 9.0 Tf [( states that once a product is detained, a "Notice of Detention and Hearing is emitted )] TJ ET BT 45.016 156.611 Td /F1 9.0 Tf [(to the importer, owner, and/or consignee, with a respond-by date for an appeal to be made. This period is usually ten to twenty )] TJ ET BT 45.016 142.874 Td /F1 9.0 Tf [(days and allows for extensions when a reasonable request is made. After an appeal is made, if the FDA considers the product )] TJ ET BT 45.016 129.138 Td /F1 9.0 Tf [(to still be in violation of a requirement an Import Refusal is emitted, and the 90-day period to either destroy or export the )] TJ ET BT 45.016 115.402 Td /F1 9.0 Tf [(product starts running with no further delays allowed. This leaves the deadline for disposal of the ventilators around late )] TJ ET BT 45.016 101.666 Td /F1 9.0 Tf [(January 2021. The FDA, however, does not require a product to remain in a physical location before its admissibility is )] TJ ET BT 45.016 87.929 Td /F1 9.0 Tf [(determined. So, the products may have entered through a port corresponding to the DNEI and were then transported to )] TJ ET BT 45.016 74.193 Td /F1 9.0 Tf [(Miami. There are also no other IRRs for Beijing Aerospace Changfeng Ltd from at least a year before April 2021, so the IRR )] TJ ET BT 45.016 60.457 Td /F1 9.0 Tf [(presented by Local 10 may correspond to the trashed ventilators, although the timeframes for the disposal dates are )] TJ ET 0.890 0.929 0.737 RG 1.5 w 0 J [ ] 0 d 64.516 518.783 147.750 83.250 re S q 146.250 0 0 81.750 65.266 519.533 cm /I3 Do Q BT 122.551 485.808 Td /F1 9.0 Tf [(1)] TJ ET BT 266.110 444.599 Td /F1 9.0 Tf [(2)] TJ ET BT 393.154 366.918 Td /F1 9.0 Tf [(3)] TJ ET BT 369.691 353.182 Td /F1 9.0 Tf [(4)] TJ ET BT 203.587 170.347 Td /F1 9.0 Tf [(5)] TJ ET endstream endobj 8 0 obj << /Type /Font /Subtype /Type1 /Name /F1 /BaseFont /Helvetica /Encoding /WinAnsiEncoding >> endobj 9 0 obj << /Type /Font /Subtype /Type1 /Name /F2 /BaseFont /Helvetica-Oblique /Encoding /WinAnsiEncoding >> endobj 10 0 obj << /Type /Font /Subtype /Type1 /Name /F3 /BaseFont /Times-Roman /Encoding /WinAnsiEncoding >> endobj 11 0 obj << /Type /Font /Subtype /Type1 /Name /F4 /BaseFont /Helvetica-Bold /Encoding /WinAnsiEncoding >> endobj 12 0 obj << /Type /XObject /Subtype /Image /Width 588 /Height 130 /Filter /FlateDecode /DecodeParms << /Predictor 15 /Colors 1 /Columns 588 /BitsPerComponent 8>> /ColorSpace /DeviceGray /BitsPerComponent 8 /Length 8715>> stream x]OK#MDA+x !\K ބ {o/|ygz&Y}Nt]]]UyD~|VVd`蓨CFAgy~u2W!Bm}u%2gSFDK_]惂la蓨-L}U)ϢKݯDFsA0_]恊W"+ Sk<`k
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