USFDA inspects Marksans’s subsidiary Time-Cap Laboratories' manufacturing facility

USFDA inspects Marksans’s subsidiary Time-Cap Laboratories' manufacturing facility

By: IPP Bureau

Last updated : May 01, 2025 11:29 am



The Subsidiary has received one inspectional observation in Form 483


Marksans Pharma Limited has announced that 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 from 16th April 2025 to 24th April 2025.

On conclusion of the inspection, the Subsidiary has received one inspectional observation in Form 483. There is no data integrity observation. The Subsidiary will work closely with the USFDA and is committed to address the observation comprehensively within the stipulated time.

USFDA Marksans Pharma Limited Time-Cap Laboratories

First Published : May 01, 2025 12:00 am