Gland Chemicals Private Limited - 11/27/2025. Country: India. Record Type: 483

Task Description Request Please post to the 2019 Pharmacy Inspections and Related Records Web page Record Date 04/17/2019 Short Title (70 char) Cascade Poulsbo Pharmacy 483 Issued 04/17/2019 FEI Number 3015133983 Firm Name Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty Pharmacy Record Type

FDA launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.

Novo Nordisk Inc. - 2/7/2026. Country: New Jersey, United States. Record Type: 483

The U.S. Food and Drug Administration today approved expanded use of Wellcovorin (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1).

The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, which are like “generic” versions of biologic drugs.

FDA held a meeting with several states to discuss the section 804 importation program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer.

Maiva Pharma Private Limited - 2/20/2026. Country: India. Record Type: 483