WebMay 19, 2024 · Your notification should refer to Warning Letter CMS # 598537 and reference FEI 1000208853. If you have questions, please contact Compliance Officer CDR Liatte Closs at [email protected] ... WebFood and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 WARNING LETTER AUG 12, 2015 VIA UNITED PARCEL SERVICE Akihiro Okubo, …
FDAの警告書（Waring Letter）への序章｜ニュース&コラム｜品 …
WebJan 12, 2024 · Olena Yakobchuk via Getty Images. Olympus Medical has received two warning letters from the Food and Drug Administration over safety issues related to reprocessing endoscopes, which involves … WebA Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [1] While the FDA generally determines violations through its … ridgid 35s cutter
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WebNov 2, 2024 · Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug … WebFood and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 WARNING LETTER AUG 12, 2015 VIA UNITED PARCEL SERVICE Akihiro Okubo, President Olympus Medical Systems Corporation 2951 Ishikawa-cho, Hachioji-shi Tokyo 192-8507, Japan Dear Mr. Okubo: The United States Food and Drug Administration … WebJan 28, 2024 · January 22, 2024. Warning Letter 320-20-20. Dear Mr. Xu: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Sunstar Guangzhou Ltd., FEI 3009449945, at Blk D, 5 ... ridgid 350 press tool