Indoco Remedies receives 4 USFDA observations for Goa facilities
Mumbai: Indoco Remedies Limited has announced that the United States Food and Drug Administration (USFDA) has issued four observations after GMP inspection of the company's Plant II (Sterile Facility) and Plant III (OSD Facility) at Goa.
The inspection was conducted from 20th February, 2023 to 28th February, 2023.
"The USFDA has issued Form 483 with four (4) observations, which will be addressed within stipulated time. We believe that this will not have an impact on the supplies and the existing revenues from these Facilities," Indoco Remedies 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 maintain compliances across all our facilities with cGMP quality standards at all times," Indoco added.
Medical Dialogues Team had earlier reported that the USFDA had issued 9 observations after GMP inspection at the company's Solid Oral Formulation Facility (Plant 1) at Goa.
Read also: USFDA inspection: Indoco Remedies gets 9 observations for Goa facility
Headquartered in Mumbai, Indoco Remedies Ltd., is a fully integrated, research-oriented pharma company engaged in the manufacturing and marketing of Formulations (Finished Dosage Forms) and Active Pharmaceutical Ingredients (APIs). The company has 9 manufacturing facilities, out of which, 6 are for finished dosages and 3 for APIs, supported by a state-of-the-art R&D centre at Rabale, Navi Mumbai and a Clinical Research Organisation at Hyderabad. Its manufacturing facilities have been approved by various regulatory authorities such as, USFDA, UK-MHRA, TGA-Australia, SAHPRA-South Africa, NDA-Uganda, TMDA-Tanzania, MOH-Ukraine, PPB-Kenya, DPML-Ivory Coast, etc.
Indoco offers complete solutions, including product development, manufacture and supply of Finished Dosages, APIs and Intermediates to generic companies worldwide. The company has a large basket of products backed by ANDAs / eCTD Dossiers and Drug Master Files (DMFs).
Read also: Indoco Remedies successfully concludes USFDA inspection of CRO Anacipher in Hyderabad
