Marksans Pharma arm New York facility gets 1 USFDA observation
Mumbai: Marksans Pharma has announced that the US Food and Drug Administration (USFDA) has concluded an inspection with one inspectional observation at the New York manufacturing facility of the Company's wholly owned subsidiary Time-Cap Laboratories, Inc.
The inspection was held from 16th April 2025 to 24th April 2025.
"A current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the manufacturing facility of the Company’s wholly owned subsidiary Time-Cap Laboratories, Inc. located at 7, Michael Avenue, Farmingdale, New York, USA (“the Subsidiary”) from 16th April 2025 to 24th April 2025," the Company stated in a BSE filing.
"On conclusion of the inspection, the Subsidiary has received One (1) inspectional observation in Form 483," Marksans stated.
Read also: Marksans Pharma arm bags UKMHRA marketing authorization for Rasagiline Relonchem, Olmesartan tablets
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. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant.
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