USFDA issues Form 483 with 9 observations to Indoco Remedies, Goa

"The Company is committed to maintain compliances across all our facilities with cGMP quality standards at all times," Indoco Remedies added.

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USFDA Inspection audit Form 483
USFDA Form 483

Last Updated on December 31, 2023 by The Health Master

Mumbai: Indoco Remedies has announced that the United States Food and Drug Administration (USFDA) has issued 9 observations after GMP inspection at the Solid Oral Formulation Facility (Plant 1) at Goa.

The inspection was conducted from 16th January, 2023 to 20th January 2023.

“We would like to inform you that the USFDA has conducted GMP inspection of the Solid Oral Formulation Facility (Plant 1) at Goa.”

“The inspection was conducted from 16th January, 2023 to 20th January 2023,” the company stated in a BSE filing.

“The USFDA has issued Form 483 with 9 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 this facility,” the company further stated.

“The Company is committed to maintain compliances across all our facilities with cGMP quality standards at all times,” Indoco Remedies added.

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 are complying with WHO-cGMP guidelines and 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.

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