FDA – Warning Letter – October 20, 2023

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 211 (21 CFR parts 210 … Read more

FDA 483 Warning Letter Dated MARCH 30

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, processing, packing, or holding do … Read more

All Post URL of Drugs formulations

Drugsformulations -

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 Tablet (drugsformulations.com) Norethisterone Tablet (drugsformulations.com) Metformin … Read more

FDA – Warning Letter 

A 15 -

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 … Read more

Pharma FDA Warning Letter for Derma Pharm A/S MARCS-CMS – November 26

A 15 -

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 … Read more

Pharma FDA Warning Letter for OHM Pharma, Inc -November 19

A 15 -

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 … Read more

Pharma FDA Warning Letter for Alkermes, Inc.

A 15 -

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 … Read more

FDA -WARNING LETTER -March 30, 2023

A 15 -

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 … Read more

Pharma FDA Warning Letter October 4, 2023

A 15 -

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 … Read more