USFDA WARNING LETTER

Warning Letter – October 20, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, from February 20 to March 2, 2023. 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 …

FDA 483 Warning Letter Dated MARCH 30, 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 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, …

All Post URL of Drugs formulations Tablets MFR of Albendazole Tablets – (drugsformulations.com) MFR of Alfacalcidol & Calcium Carbonate Tablets (drugsformulations.com) MFR of Sildenafil Citrate Tablets (drugsformulations.com) MFR of Paracetamol & Dicyclomine HCl Tablets – (drugsformulations.com) MFR of Dextromethorphan, Bromhexine, Chlorpheniramine Maleate & Guaifenesin  Tablets (drugsformulations.com) Dextromethorphan (drugsformulations.com) Spiramycin Tablet (drugsformulations.com) MFR of Propranolol Hydrochloride …

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 …

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 …

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 …

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 …

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 …

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) …

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), …

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 …

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), …

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 …

FDA Pharma FDA Warning Letter September 14, 2023 The United States Food and Drug Administration (FDA) conducted an inspection of 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 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 …

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. …

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) …

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) …

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 …

                  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 …