{"id":20676,"date":"2018-07-22T01:00:00","date_gmt":"2018-08-08T01:20:39","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/08\/08\/fda%e8%ad%a6%e5%91%8a%e4%bf%a1%ef%bc%9a%e5%8d%b0%e5%ba%a6claris-injectables-ltd\/"},"modified":"2018-08-08T09:20:40","modified_gmt":"2018-08-08T01:20:40","slug":"fda%e8%ad%a6%e5%91%8a%e4%bf%a1%ef%bc%9a%e5%8d%b0%e5%ba%a6claris-injectables-ltd","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/20676\/","title":{"rendered":"FDA\u8b66\u544a\u4fe1\uff1a\u5370\u5ea6Claris Injectables Ltd."},"content":{"rendered":"
\n

<\/span>\u7ffb\u8bd1\uff1a JULIA\u6765\u6e90\uff1a <\/span>Julia\u6cd5\u89c4\u7ffb\u8bd1<\/span> <\/span><\/span><\/p>\n


<\/span><\/p>\n

Warning Letter <\/span><\/strong>320-18-62                  July 5, 2018<\/span><\/span><\/p>\n

           <\/span><\/p>\n

Amish Vyas<\/span><\/p>\n

Managing Director, Baxter(Claris Injectables Ltd.)<\/span><\/p>\n

Nr. Parimal Railway Crossing Ellisbridge, Ahmedabad- 380006 Gujarat, India<\/span><\/p>\n

 <\/span><\/p>\n

Dear Mr. Vyas:<\/span><\/p>\n

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Claris Injectables Ltd. at Ahmedabad, from July27, 2017 to August 4, 2017.<\/span><\/p>\n

\u7f8e\u56fd<\/span>FDA<\/span>\u4e8e<\/span>2017<\/span>\u5e74<\/span>7<\/span>\u6708<\/span>27<\/span>\u65e5\u81f3<\/span>8<\/span>\u6708<\/span>4<\/span>\u65e5\u68c0\u67e5\u4e86\u4f60\u4eec\u5370\u5ea6\u7684<\/span>Claris Injectables Ltd.<\/span>\u751f\u4ea7\u573a\u6240\u3002<\/span><\/span><\/p>\n

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.<\/span><\/p>\n

 <\/span>\u672c\u8b66\u544a\u4fe1\u603b\u7ed3\u4e86\u5236\u5242\u751f\u4ea7\u4e25\u91cd\u8fdd\u53cd<\/span>CGMP<\/span>\u7684\u884c\u4e3a\u3002\u53c2\u89c1<\/span>21CFR<\/span>\u7b2c<\/span>210<\/span>\u548c<\/span>211<\/span>\u90e8\u5206\u3002<\/span><\/span><\/p>\n

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).<\/span><\/p>\n

\u7531\u4e8e\u4f60\u4eec\u7684\u836f\u54c1\u751f\u4ea7\u3001\u52a0\u5de5\u3001\u5305\u88c5\u6216\u4fdd\u5b58\u7684\u65b9\u6cd5\u3001\u573a\u6240\u6216\u63a7\u5236\u4e0d\u7b26\u5408<\/span>CGMP<\/span>\u8981\u6c42\uff0c\u4f60\u4eec\u7684\u836f\u54c1\u6839\u636e<\/span>FDCA<\/span>\u7684<\/span>501(a)(2)(B)<\/span>\u4ee5\u53ca<\/span>21U.S.C. 351(a)(2)(B)<\/span>\u88ab\u8ba4\u4e3a\u662f\u63ba\u5047\u836f\u54c1\u3002<\/span><\/span><\/p>\n

We reviewed your August 25, 2017 response in detail and acknowledge receipt of your subsequent correspondence.<\/span><\/p>\n

\u6211\u4eec\u5df2\u8be6\u7ec6\u5ba1\u6838\u4e86\u4f60\u516c\u53f8<\/span>2017<\/span>\u5e74<\/span>8<\/span>\u6708<\/span>25<\/span>\u65e5\u7684\u56de\u590d\u3002\u5728\u6b64\u544a\u77e5\u4f60\u4eec\u540e\u7eed\u901a\u4fe1\u4ea6\u5df2\u6536\u6089\u3002<\/span><\/span><\/p>\n

During our inspection, our investigators observed specific violations including, but not limited to, the following.<\/span><\/p>\n

 <\/span>\u68c0\u67e5\u671f\u95f4\uff0c\u6211\u4eec\u7684\u8c03\u67e5\u4eba\u5458\u53d1\u73b0\u7684\u5177\u4f53\u95ee\u9898\u5305\u62ec\u4f46\u4e0d\u4ec5\u9650\u4e8e\u4ee5\u4e0b\uff1a<\/span><\/span><\/p>\n

1.    Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). <\/span><\/span><\/strong> <\/span><\/strong>\u4f60\u516c\u53f8\u672a\u80fd\u5f7b\u5e95\u8c03\u67e5\u5df2\u9500\u552e\u548c\u672a\u9500\u552e\u4ea7\u54c1\u6279\u6b21\u6216\u5176\u7ec4\u4efd\u6240\u6709\u672a\u80fd\u89e3\u91ca\u7684\u4e0e\u8d28\u91cf\u6807\u51c6\u7684\u5dee\u5f02\u6216\u4e0d\u7b26\u5408\u8d28\u91cf\u6807\u51c6\u7684\u60c5\u51b5<\/span><\/strong>(21 CFR 211.192)<\/span><\/strong>\u3002<\/span><\/strong><\/span><\/p>\n

Your firm invalidated out-of-specification (OOS) results without adequate investigation and scientific justification. Examples include:<\/span><\/p>\n

 <\/span>\u4f60\u516c\u53f8\u672a\u7ecf\u5145\u5206\u8c03\u67e5\u548c\u79d1\u5b66\u8bba\u8bc1\u5373\u5ba3\u5e03<\/span>OOS<\/span>\u7ed3\u679c\u65e0\u6548\u3002\u4f8b\u5982\uff1a<\/span><\/span><\/p>\n

a.    In January, 2017, you obtained OOS results for the (b)(4)<\/strong> impurity during stability testing of (b)(4)<\/strong> injection batches (b)(4)<\/strong>. Your OOS investigation reports stated that the postulated cause was \u201cpoor column efficiency,\u201d although no chromatographic abnormalities were noted and system suitability criteria were met. During the inspection, your lab management indicated that retention times, the oreticalplates, and tailing factor appeared appropriate and no specific root cause had been demonstrated. You repeated the analyses, obtained passing results, and invalidated the OOS results.<\/span><\/p>\n

 2017<\/span>\u5e74<\/span>1<\/span>\u6708\uff0c\u4f60\u4eec\u5728<\/span>XX<\/span>\u6ce8\u5c04\u6db2\u6279\u53f7<\/span>XX<\/span>\u7684\u7a33\u5b9a\u6027\u6d4b\u8bd5\u671f\u95f4\u5f97\u5230<\/span>XX<\/span>\u6742\u8d28<\/span>OOS<\/span>\u7ed3\u679c\u3002\u4f60\u4eec\u7684<\/span>OOS<\/span>\u8c03\u67e5\u62a5\u544a\u8bf4\u5047\u5b9a\u539f\u56e0\u662f\u201c\u67f1\u6548\u592a\u5dee\u201d\uff0c\u4f46\u5e76\u672a\u6ce8\u610f\u5230\u6709\u8272\u8c31\u5f02\u5e38\uff0c\u7cfb\u7edf\u9002\u7528\u6807\u51c6\u4e5f\u662f\u7b26\u5408\u7684\u3002\u5728\u68c0\u67e5\u671f\u95f4\uff0c\u4f60\u4eec\u5316\u9a8c\u5ba4\u7ba1\u7406\u4eba\u5458\u8bf4\u4fdd\u7559\u65f6\u95f4\u3001\u7406\u8bba\u5854\u677f\u6570\u548c\u62d6\u5c3e\u56e0\u5b50\u663e\u793a\u6b63\u5e38\uff0c\u5e76\u672a\u8bc1\u660e\u6709\u5177\u4f53\u7684\u6839\u672c\u539f\u56e0\u3002\u4f60\u4eec\u91cd\u65b0\u8fdb\u884c\u4e86\u68c0\u9a8c\uff0c\u5f97\u5230\u4e86\u5408\u683c\u7ed3\u679c\uff0c\u5e76\u4e14\u5ba3\u5e03<\/span>OOS<\/span>\u7ed3\u679c\u65e0\u6548\u3002<\/span><\/span><\/p>\n

In March, 2017, you obtained OOS results for the (b)(4)<\/strong> impurity during stability testing of (b)(4)<\/strong> injection batches (b)(4)<\/strong>.You suspected the analyst may have incorrectly rinsed the HPLC vials. New samples prepared and tested by a second analyst using both the original column and a new column, as well as old and new vials, also yielded OOS results.Although you lacked sufficient evidence, your investigation concluded that the OOS results were due to sample vial contamination. You invalidated the OOS results after obtaining passing results from testing retain samples.<\/span><\/p>\n

2017<\/span>\u5e74<\/span>3<\/span>\u6708\uff0c\u4f60\u4eec\u5728<\/span>XX<\/span>\u6ce8\u5c04\u6db2\u6279\u53f7<\/span>XX<\/span>\u7684\u7a33\u5b9a\u6027\u6d4b\u8bd5\u671f\u95f4\u5f97\u5230<\/span>XX<\/span>\u6742\u8d28<\/span>OOS<\/span>\u7ed3\u679c\u3002\u4f60\u4eec\u6000\u7591\u662f\u5316\u9a8c\u5458\u6dcb\u6d17<\/span>HPLC<\/span>\u8fdb\u6837\u74f6\u9519\u8bef\u3002\u7b2c\u4e8c\u4e2a\u5316\u9a8c\u5458\u5236\u5907\u4e86\u65b0\u6837\u54c1\uff0c\u4f7f\u7528\u539f\u59cb\u67f1\u548c\u4e00\u652f\u65b0\u67f1\uff0c\u8fd8\u6709\u539f\u59cb\u74f6\u4e0e\u4e00\u652f\u65b0\u8fdb\u6837\u74f6\uff0c\u5206\u522b\u8fdb\u884c\u4e86\u68c0\u6d4b\uff0c\u4e5f\u5f97\u5230\u4e86<\/span>OOS<\/span>\u7ed3\u679c\u3002\u5c3d\u7ba1\u4f60\u4eec\u7f3a\u4e4f\u8db3\u591f\u7684\u8bc1\u636e\uff0c\u4f60\u4eec\u7684\u8c03\u67e5\u4ecd\u7ed9\u51fa\u7ed3\u8bba\u8bf4<\/span>OOS<\/span>\u7ed3\u679c\u662f\u56e0\u4e3a\u8fdb\u6837\u74f6\u6c61\u67d3\u3002\u4f60\u4eec\u5728\u5bf9\u7559\u6837\u8fdb\u884c\u68c0\u9a8c\u5f97\u5230\u5408\u683c\u7ed3\u679c\u4e4b\u540e\u5ba3\u5e03\u4e86<\/span>OOS<\/span>\u7ed3\u679c\u65e0\u6548\u3002<\/span><\/span><\/p>\n

After the conclusion of the inspection you initiated a voluntary recall of five batches of (b)(4)<\/strong> drug product due to failing (b)(4)<\/strong> levels, superpotent assays, and (b)(4)<\/strong>, all obtained during stability testing and including batches (b)(4)<\/strong>.<\/span><\/p>\n

 <\/span>\u5728\u68c0\u67e5\u51fa\u7ed3\u8bba\u4e4b\u540e\uff0c\u4f60\u4eec\u542f\u52a8\u4e86<\/span>5<\/span>\u6279<\/span>XX<\/span>\u836f\u54c1\u4e3b\u52a8\u53ec\u56de\uff0c\u539f\u56e0\u662f<\/span>XX<\/span>\u6c34\u5e73\u4e0d\u5408\u683c\u3001\u542b\u91cf\u8fc7\u9ad8\u4ee5\u53ca<\/span>XX<\/span>\uff0c\u8fd9\u4e9b\u90fd\u662f\u5728\u7a33\u5b9a\u6027\u7814\u7a76\u671f\u95f4\u5f97\u5230\u7684\u7ed3\u679c\uff0c\u6db5\u76d6\u6709\u6279\u6b21<\/span>XX<\/span>\u3002<\/span><\/span><\/p>\n

Notably, you informed FDA that the apparent root cause ofthe (b)(4)<\/strong> assay failures was excessive (b)(4) <\/strong>from your (b)(4)<\/strong>.However, the investigation lacked an adequate assessment of all other batches distributed to the U.S. and within expiry that may be potentially affected by (b)(4)<\/strong>.<\/span><\/p>\n

 <\/span>\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u4f60\u4eec\u901a\u77e5<\/span>FDA<\/span>\u8bf4<\/span>XX<\/span>\u542b\u91cf\u4e0d\u5408\u683c\u7684\u660e\u663e\u6839\u672c\u539f\u56e0\u662f<\/span>XX<\/span>\u9ad8\u51fa\u4f60\u4eec\u7684<\/span>XX<\/span>\u3002\u4f46\u662f\uff0c\u8be5\u8c03\u67e5\u7f3a\u4e4f\u5bf9\u6240\u6709\u5176\u5b83\u53ef\u80fd\u53d7<\/span>XX<\/span>\u5f71\u54cd\u3001\u5df2\u9500\u5f80\u7f8e\u56fd\u4e14\u4ecd\u5728\u6548\u671f\u5185\u7684\u6279\u6b21\u8fdb\u884c\u7684\u8db3\u591f\u8bc4\u4f30\u3002<\/span><\/span><\/p>\n

b.    Your OOS investigation of the failureof (b)(4)<\/strong> batches (b)(4) <\/strong>to meet the (b)(4) <\/strong>specifications under accelerated stability conditions was also inadequate. You obtained OOS results of (b)(4)<\/strong>% and (b)(4)<\/strong>%, respectively (specification Not More Than (b)(4)<\/strong>%). While the investigation lacked a demonstrated assignable root cause in the laboratory, you obtained passing results during repeat analysis and invalidated the OOS without a Phase II production investigation.<\/span><\/p>\n

 <\/span>\u4f60\u4eec\u5bf9<\/span>XX<\/span>\u6279\u6b21<\/span>XX<\/span>\u5728\u52a0\u901f\u7a33\u5b9a\u6027\u6761\u4ef6\u4e0b\u4e0d\u7b26\u5408<\/span>XX<\/span>\u8d28\u91cf\u6807\u51c6\u7684<\/span>OOS<\/span>\u8c03\u67e5\u662f\u4e0d\u5145\u5206\u7684\u3002\u4f60\u4eec\u5f97\u5230\u7684<\/span>OOS<\/span>\u7ed3\u679c\u5206\u522b\u662f<\/span>XX%<\/span>\u548c<\/span>XX%<\/span>\uff08\u6807\u51c6\u4e3a\u4e0d\u5f97\u8fc7<\/span>XX%<\/span>\uff09\u3002\u8c03\u67e5\u5e76\u672a\u8bc1\u660e\u5316\u9a8c\u5ba4\u5185\u53ef\u5f52\u7ed3\u6839\u672c\u539f\u56e0\uff0c\u4f60\u4eec\u5728\u590d\u6d4b\u4e2d\u5f97\u5230\u4e86\u5408\u683c\u7ed3\u679c\uff0c\u7136\u540e\u672a\u8fdb\u884c\u7b2c\u4e8c\u9636\u6bb5\u751f\u4ea7\u8c03\u67e5\u5373\u5ba3\u5e03\u4e86<\/span>OOS<\/span>\u7ed3\u679c\u65e0\u6548\u3002<\/span><\/span><\/p>\n

After the inspection, you recalled eight batches of (b)(4) <\/strong>due to superpotent assay and (b)(4) <\/strong>results obtained during stabilitytesting. While use of substandard (b)(4) <\/strong>that allow excessive (b)(4) <\/strong>again appears to have caused the specification failures, your response lacked sufficient relevant information on the root cause and scope of this major problem.<\/span><\/p>\n

 <\/span>\u5728\u68c0\u67e5\u4e4b\u540e\uff0c\u7531\u4e8e\u7a33\u5b9a\u6027\u7814\u7a76\u671f\u95f4\u542b\u91cf\u8d85\u9ad8\u548c<\/span>XX<\/span>\u7ed3\u679c\uff0c\u4f60\u4eec\u53ec\u56de\u4e86<\/span>8<\/span>\u4e2a<\/span>XX<\/span>\u6279\u6b21\u3002\u4f60\u4eec\u4f7f\u7528\u4e86\u4e0d\u5408\u6807\u51c6\u7684<\/span>XX<\/span>\u4f7f\u5f97\u91cd\u590d\u51fa\u73b0<\/span>XX<\/span>\u8d85\u51fa\uff0c\u5bfc\u81f4\u4e86\u4e0d\u7b26\u5408\u8d28\u91cf\u6807\u51c6\u7684\u60c5\u51b5\u51fa\u73b0\u3002\u4f60\u4eec\u7684\u56de\u590d\u7f3a\u4e4f\u8db3\u591f\u7684\u6839\u672c\u539f\u56e0\u65b9\u9762\u5173\u8054\u4fe1\u606f\uff0c\u6ca1\u6709\u6b64\u91cd\u5927\u95ee\u9898\u7684\u8303\u56f4\u754c\u5b9a\u3002<\/span><\/span><\/p>\n

In both of the above instances, you failed to expand your OOS investigations in a timely fashion to address potential manufacturing causes. When an investigation lacks conclusive evidence of laboratory error, athorough investigation of potential manufacturing causes must be performed. Your acceptance of the passing results from testing a new set of samples basedon an unproven hypothesis was insufficient to conclude the investigations.<\/span><\/p>\n

\u5728\u4e0a\u8ff0\u4e24\u8d77\u4e8b\u4ef6\u4e2d\uff0c\u4f60\u4eec\u5747\u672a\u80fd\u53ca\u65f6\u6269\u5927\u4f60\u4eec\u7684<\/span>OOS<\/span>\u8c03\u67e5\uff0c\u8bf4\u660e\u6f5c\u5728\u7684\u751f\u4ea7\u539f\u56e0\u3002\u5f53\u4e00\u4e2a\u8c03\u67e5\u7f3a\u4e4f\u7ed3\u8bba\u6027\u8bc1\u636e\u8bc1\u660e\u5316\u9a8c\u5ba4\u9519\u8bef\u65f6\uff0c\u5fc5\u987b\u5bf9\u6f5c\u5728\u7684\u751f\u4ea7\u539f\u56e0\u8fdb\u884c\u5f7b\u5e95\u8c03\u67e5\u3002\u4f60\u4eec\u6839\u636e\u4e00\u4e2a\u672a\u7ecf\u8bc1\u5b9e\u7684\u5047\u8bbe\uff0c\u91cd\u65b0\u68c0\u6d4b\u4e86\u4e00\u5957\u65b0\u7684\u6837\u54c1\uff0c\u63a5\u53d7\u4e86\u5176\u5408\u683c\u7ed3\u679c\uff0c\u8fd9\u6837\u505a\u51fa\u8c03\u67e5\u7ed3\u8bba\u662f\u4e0d\u5145\u5206\u7684\u3002<\/span><\/span><\/p>\n

Your response stated that you will revise your OOS Management<\/em> procedure and perform a retrospective review of your OOS investigations.Your response was inadequate because it lacked identification of root causesand implementation of effective corrective actions and preventive actions (CAPA). It also failed to address inadequacies in the (b)(4)<\/strong> you received from your supplier(s), and whether they are still considered qualifiedfor use by your firm.<\/span><\/p>\n

\u4f60\u4eec\u7684\u56de\u590d\u8bf4\u4f60\u4eec\u4f1a\u4fee\u8ba2\u4f60\u4eec\u7684<\/span>OOS<\/span>\u7ba1\u7406\u7a0b\u5e8f\uff0c\u5bf9\u4f60\u4eec\u7684<\/span>OOS<\/span>\u8c03\u67e5\u5b9e\u65bd\u56de\u987e\u6027\u5ba1\u6838\u3002\u4f60\u4eec\u7684\u56de\u590d\u662f\u4e0d\u5145\u5206\u7684\uff0c\u56e0\u4e3a\u5b83\u7f3a\u4e4f\u5bf9\u6839\u636e\u539f\u56e0\u7684\u8bc6\u522b\uff0c\u4ee5\u53ca\u5b9e\u65bd\u6709\u6548\u7684<\/span>CAPA<\/span>\u3002\u5b83\u4e5f\u6ca1\u6709\u89e3\u51b3\u4f60\u4eec\u4ece\u4f9b\u5e94\u5546\u5904\u6536\u5230\u7684<\/span>XX<\/span>\u4e2d\u7684\u4e0d\u5145\u5206\u7684\u60c5\u51b5\uff0c\u4ee5\u53ca\u4f60\u4eec\u516c\u53f8\u662f\u5426\u4ecd\u5c06\u5176\u4f5c\u4e3a\u5408\u683c\u4f9b\u5e94\u5546\u53ef\u4ee5\u4f7f\u7528\u3002<\/span><\/span><\/p>\n

Notably, your firm has had a worrisome history of recalls dueto substandard (b)(4)<\/strong>. In 2017, you recalled (b)(4) <\/strong>parenteral drug products due to recurring(b)(4) <\/strong>complaints. In 2010, your firm conducted a Class I recall of all lots of four parenteral products due to loss of (b)(4)<\/strong> integrity and non-sterility.  <\/span><\/p>\n

\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u4f60\u4eec\u516c\u53f8\u5df2\u7ecf\u6709\u8fc7\u56e0\u4f4e\u6807\u51c6<\/span>XX<\/span>\u800c\u53ec\u56de\u7684\u4e0d\u826f\u5386\u53f2\u3002\u5728<\/span>2017<\/span>\u5e74\uff0c\u4f60\u4eec\u53ec\u56de\u4e86<\/span>XX<\/span>\u6ce8\u5c04\u836f\u54c1\uff0c\u539f\u56e0\u662f\u91cd\u590d\u53d1\u751f\u7684<\/span>XX<\/span>\u6295\u8bc9\u3002\u5728<\/span>2010<\/span>\u5e74\uff0c\u4f60\u4eec\u516c\u53f8\u5bf9<\/span>4<\/span>\u4e2a\u6ce8\u5c04\u836f\u54c1\u6240\u6709\u6279\u6b21\u6267\u884c\u4e86<\/span>I<\/span>\u7ea7\u53ec\u56de\uff0c\u539f\u56e0\u662f<\/span>XX<\/span>\u5b8c\u6574\u6027\u5931\u8d25\u548c\u65e0\u83cc\u95ee\u9898\u3002<\/span><\/span><\/p>\n

Also, while your firm has discussed adding a (b)(4) <\/strong>as a corrective action for (b)(4)<\/strong>, it would not resolve ongoing issues relating to quality of container-closure raw materials or (b)(4) <\/strong>fabrication. Durability and quality of your large volume parenteral container-closure systems is critical to ensure their robustness until administration at a clinical facility, who will remove (b)(4)<\/strong>, and cantemporarily store and then transfer the (b)(4)<\/strong> within the facility before use. Your response lacks a commitment to thoroughly review your (b)(4)<\/strong> dependability with respect to both container-closure raw material quality and (b)(4)<\/strong> fabrication process weaknesses.<\/span><\/p>\n

\u8fd8\u6709\uff0c\u867d\u7136\u4f60\u4eec\u516c\u53f8\u5df2\u7ecf\u8ba8\u8bba\u4e86\u589e\u52a0\u4e00\u4e2a<\/span>XX<\/span>\u4f5c\u4e3a<\/span>XX<\/span>\u7684\u7ea0\u6b63\u63aa\u65bd\uff0c\u4f46\u8fd9\u5e76\u4e0d\u80fd\u89e3\u51b3\u6301\u7eed\u53d1\u751f\u7684\u4e0e\u5bb9\u5668\u5bc6\u95ed\u5668\u539f\u6599\u6216<\/span>XX<\/span>\u5236\u9020\u7684\u8d28\u91cf\u6709\u5173\u95ee\u9898\u3002\u4f60\u4eec\u5927\u5bb9\u5668\u6ce8\u5c04\u5242\u5bb9\u5668\u5bc6\u95ed\u5668\u7cfb\u7edf\u7684\u8010\u7528\u6027\u548c\u8d28\u91cf\u5bf9\u4e8e\u786e\u4fdd\u5176\u7a33\u56fa\u6027\u76f4\u5230\u5728\u4e34\u5e8a\u8bbe\u65bd\u91cc\u88ab\u4f7f\u7528\u662f\u81f3\u5173\u91cd\u8981\u7684\u3002\u5728\u4e34\u5e8a\u573a\u5408\uff0c<\/span>XX<\/span>\u4f1a\u88ab\u79fb\u9664\uff0c\u53ef\u4ee5\u4e34\u65f6\u5b58\u8d2e\uff0c\u7136\u540e\u8f6c\u79fb\u81f3\u8bbe\u65bd\u5185\u7684<\/span>XX<\/span>\u91cc\u76f4\u81f3\u4f7f\u7528\u3002\u4f60\u4eec\u7684\u56de\u590d\u7f3a\u4e4f\u8fdb\u884c\u5bf9\u4f60\u4eec\u5bb9\u5668\u5bc6\u95ed\u5668\u539f\u6599\u548c<\/span>XX<\/span>\u5236\u9020\u5de5\u827a\u5f31\u70b9\u7684\u72ec\u7acb\u6027\u8fdb\u884c\u5f7b\u5e95\u5ba1\u6838\u7684\u627f\u8bfa\u3002<\/span><\/span><\/p>\n

In response to this letter, provide:<\/span><\/p>\n

\u56de\u590d\u6b64\u51fd\u65f6\u8bf7\u63d0\u4ea4\uff1a<\/span><\/p>\n