Pharma FDA Warning Letter -October 2, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Seoul Cosmetics Co., Ltd., FEI 3007253462, at 12, Namdongdong-ro 63beon-Gil, Namdong-gu, from January 30 to February 3, 2023. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title…
FDA Warning Letter -October 2, 2023 This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.gorillahealing.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), and 505(a) of the…
FDA Pharma Warning Letter -September 2023 During an inspection of your firm located at 22 Cherry Hill Drive, Danvers, MA on March 1, 2023 through April 13, 2023, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a Medical Device Manufacturer of class III devices, the Impella 2.5, Impella…
FDA Pharma FDA Warning Letter September 14, 2023 The United States Food and Drug Administration (FDA) inspected your firm, Fenwal International, Inc. (a Fresenius Kabi company), located at Road 357, Km 0.8, Maricao, PR 00606, between September 12, 2022 and September 24, 2022. During the inspection, the FDA investigators documented significant deviations from current good…
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FDA Warning Letter September 1, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, PureChemPros LLC, FEI 3019411371, at 2141 E. Cedar Street, Suite 6, Tempe, from November 17 to November 22, 2022. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title…
Pharma FDA Warning Letter 9/11/2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility Kor-Chem, Inc., FEI 3000204701, at 5800 Bucknell Drive SW, Atlanta from April 26 to May 5, 2023. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of…
Pharma FDA Warning Letter September 5, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Safecor Health LLC, FEI # 1218914 at 317 New Boston St., Woburn, Massachusetts, from March 7 to 16, 2023. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See…
Pharma FDA Warning Letter September 5, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Safecor Health LLC, FEI # 1218914 at 317 New Boston St., Woburn, Massachusetts, from March 7 to 16, 2023. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See…
Pharma FDA Warning Letter September 11 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Similasan AG, FEI 1000110034, at Chriesiweg 6, Jonen, from March 27 to April 4, 2023. This letter is to advise you that FDA reviewed the information related to the inspection, including Similasan’s response to the FDA Form…
Pharma FDA Warning Letter 17 August 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lex Inc., FEI 1031041, at 7155 NW 77th Terrace, Medley, Florida, from February 13 to February 28, 2023. This warning letter summarizes significant violations of Current Good…
Pharma FDA Warning Letter 23 August 2023 Your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 3, 2023 request for records and other information pursuant to section 704(a)(4) of the Federal…
Tismor Health and Wellness Pty Limited MARCS-CMS 588104 — December 05, 2019 For Warning Letter Click Here – 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. For more USFDA warning Letter Visit…
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Sunstar Guangzhou Ltd. MARCS-CMS 592906 — January 22, 2020 For Warning Letter Click Here – 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. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Dental-Kosmetik GmbH & Co. KG MARCS-CMS 591351 — January 16, 2020 For Warning Letter Click Here – 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. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Baja Fur S.A. de C.V. MARCS-CMS 590791 — December 13, 2019 For Warning Letter Click Here – 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. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Essnd Global MARCS-CMS 595850 — February 14, 2020 For Warning Letter Click Here – 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. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
JHS Svendgaard Hygiene Products Ltd MARCS-CMS 593473 — February 13, 2020 For Warning Letter Click Here – 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. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
KVK-Tech, Inc MARCS-CMS 592387 — February 11, 2020 For Warning Letter Click Here – 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. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Chemland Co., Ltd. MARCS-CMS 593158 — February 11, 2020 For Warning Letter Click Here – 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. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
Acino Products, LLC MARCS-CMS 589471 — February 10, 2020 For Warning Letter Click Here – 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. For more USFDA warning Letter Visit :https://pharmaguidances.com/shop/guideline/usfda-warning-letter/
