Tag: Belarus

FDA – Warning Letter September 10, 2019 For FDA 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 FDA warning Letter Visit: https://pharmaguidances.com/shop/guideline/usfda-warning-letter/ FDA – Warning…

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Teligent Pharma, Inc. MARCS-CMS 587592 — November 26, 2019 For FDA 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 FDA Pharma warning Letter Visit…

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Pharma FDA Warning Letter for OHM Pharma, Inc MARCS-CMS 586428 — November 19, 2019 For FDA 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…

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For FDA Warning Letter Click Here –   Alkermes, Inc. MARCS-CMS 597260 — December 02, 2019 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/ FDA…

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FDA -WARNING LETTER -March 30, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, ALI Pharmaceutical Manufacturing, LLC, FEI 1920841, at 4410 S. 102nd Street, Omaha, from September 26 to October 3, 2022. This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). Because…

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Pharma FDA Warning Letter October 4, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Handock Cosmetics Co., Ltd., FEI 3007295883, at 19 Eunbong-ro, Namdong-gu, Incheon 21634, from March 20 to March 24, 2023. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See…

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Pharma FDA Warning Letter -October 16, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility from April 26 to May 9, 2022. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21…

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