Last Updated on January 4, 2024 by The Health Master
Mumbai: Drugmaker, Glenmark Pharma, has recently announced that the US Food and Drug Administration (USFDA) has issued Form 483 with five observations after an inspection at the Company’s formulation manufacturing facility based out of Goa, India.
The inspection was conducted between May 12, 2022 and May 20, 2022.”This is to inform you that the USFDA has issued Form 483 with five observations after an inspection at the Company’s formulation manufacturing facility based out of Goa, India between May 12, 2022 and May 20, 2022,” the company stated in a BSE filing.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
“The company is committed to undertake all necessary steps required to address their observations at the earliest.
The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe,” Glenmark added.
Glenmark Pharmaceuticals Limited is a global research-led pharmaceutical company with presence across generics, specialty and OTC businesses and with operations in over 50 countries.
Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology.
USFDA gives 10 observations to Sun Pharm
USFDA gives Zero Observations to SMS Lifesciences
USFDA issues 4 Observations to Lupin for Tarapur Facility
USFDA gives 13 observations to Lupin
USFDA complete audit of Granules Pharmaceuticals with 3 observations
USFDA issues 3 observations on Zydus manufacturing unit
De-addiction center raided by joint team of FDA Haryana & Police: HM
Drug recall: Over 10,000 bottles of generic Anti-depression Drug recalled
Financial aid to the family of late Sh. Sudip Ganguly, Drug Inspector West Bengal
Govt adds psoriasis drug Acitretin under Schedule H of Drugs Rules
NPPA has launched an exercise to cap the huge margins of medicines
FDA lodged FIR for manufacturing BP monitoring machines without license
USFDA gives nod to Glenmark for Abiraterone Acetate tablets USP 500 mg
Govt amends Rules to add suspension and cancellation of license provisions…
FAQs – on Schedule-P (Expiry Date of drugs)
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
