The United States Food and Drug Administration (USFDA) has conducted the inspection at Ipca Laboratories’ formulations manufacturing unit situated at Piparia (Silvassa) from April 18, 2023 to April 26, 2023. At the conclusion of the inspection, the USFDA issued a Form 483 with 3 observations.
The company will submit its comprehensive response on these observations to the US FDA within the stipulated time and shall work closely with the agency to resolve these issues at the earliest.
Ipca Laboratories is engaged in manufacturing of active pharmaceutical ingredients and formulations.
