28-04-2025
Marksans Pharma's subsidiary receives one USFDA observation after cGMP inspection at New York facility
Marksans Pharma Limited has announced that a current Good Manufacturing Practices (cGMP) inspection was conducted by the United States Food and Drug Administration (USFDA) at the manufacturing facility of its wholly owned subsidiary, Time-Cap Laboratories, Inc. The facility is located at 7 Michael Avenue, Farmingdale, New York, USA.
The inspection took place from 16th April 2025 to 24th April 2025. Upon conclusion, Time-Cap Laboratories, Inc. received one inspectional observation through Form 483. Notably, there were no data integrity-related observations reported during the inspection.
Marksans Pharma stated that Time-Cap Laboratories, Inc. is committed to addressing the observation comprehensively and will work closely with the USFDA to ensure timely compliance within the stipulated deadlines.
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