Tag: Form 483
Solara Pharma’s manufacturing site garners positive FDA review
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 ... Read More
US FDA issues Form 483 to Alkem Laboratories for St Louis plant
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 ... Read More
FDA makes four Form 483 observations at Zydus Lifesciences facility
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 ... Read More
Alkem Laboratories issued FDA Form 483 for St. Louis facility
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 ... Read More
Glenmark issued FDA Form 483 for Monroe formulation manufacturing facility
Glenmark Pharmaceuticals said that it has been issued Form 483 with 17 observations by the US Food and Drug Administration (FDA) following an inspection at ... Read More
Alkem Laboratories gets Form 483 from US FDA for St. Louis plant
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 ... Read More