Last Updated on December 31, 2023 by The Health Master
After a GMP inspection of the company’s Plant II (Sterile Facility) and Plant III (OSD Facility) in Goa, the United States Food and Drug Administration (USFDA) has issued four observations, according to an announcement from Indoco Remedies Limited in Mumbai.
The inspection was conducted from 20th February, 2023 to 28th February, 2023.
Four (4) observations on Form 483 from the USFDA have been made, and they will be resolved within the allotted time.
“e 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.
When an investigator(s) has(have) observed any conditions that in their opinion may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts, an USFDA Form 483 is issued to firm management at the conclusion of an inspection.
“The Company is committed to maintaining compliances with cGMP quality standards across all of our facilities at all times,” Indoco continued.
The USFDA issued nine observations following a GMP inspection at the company’s Solid Oral Formulation Facility (Plant 1) in Goa, according to a previous report by Medical Dialogues Team.
Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented pharmaceutical company that manufactures and markets 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).
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