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.
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