Solara Active Pharma Sciences Ltd’s (Solara Pharma) manufacturing facility in Cuddalore has garnered approval from the US Food and Drug Administration (US FDA). Following an inspection from July 31 to August 4, 2023, the facility received a green signal, indicating its “Acceptable State of Compliance” without any Form 483 observations from the US FDA. Enhanced […]
Alkem Laboratories said that it has been issued Form 483 with a couple of observations from the US Food and Drug Administration (FDA) pertaining to its manufacturing facility located in St. Louis in the US. The FDA carried out its inspection from 6 September to 14 September 2022, said the Indian pharma company. Alkem Laboratories […]
Zydus Lifesciences (formerly known as Cadila Healthcare) said that the US Food and Drug Administration (FDA) completed an inspection of its Moraiya manufacturing plant in Ahmedabad with four Form 483 observations. The FDA inspection was held from 26 July and 5 August 2022. Zydus Lifesciences said that none of the observations made by the FDA […]
Alkem Laboratories Limited said that it has been issued Form 483 from the US Food and Drug Administration (FDA) following an inspection of its manufacturing facility in St. Louis, Missouri. The FDA has made three observations from its inspection that was held between 6 June 2022 and 17 June 2022, said the Indian pharma company. […]
Glenmark Pharmaceuticals, a global pharmaceutical company based in India, announced that it has been issued Form 483 with 17 observations by the United States Food and Drug Administration (FDA) following an inspection of its formulation manufacturing facility in Monroe, North Carolina. The inspection, which took place from April 4, 2022, to May 19, 2022, identified […]
Alkem Laboratories said that the US Food and Drug Administration (FDA) has issued Form 483 to the company with two observations. Form 483 are given by the FDA when a company is found to have violated the Food Drug and Cosmetic (FD&C) Act and related acts. Alkem Laboratories said that the FDA had undertaken an […]