Compounding this issue has been the company’s consistent struggles with manufacturing, as Novartis received a Form 483 from the FDA over issues with the production process of Kymriah.

Sun Pharma said the US FDA issued a Form-483 with eight observations after inspecting its Halol facility from June 2–13.

The U.S. Food & Drug Administration has issued a warning concerning tianeptine, also known as "gas station heroin," due to its easy access and potential for harm or death.

Enhance your regulatory compliance skills with a comprehensive course on FDA regulations for biologics and drug development. Learn practical applications for ensuring compliance with the FD&C Act ...

A drug currently used to treat certain HIV infections has also, on Wednesday, received approval from the US Food and Drug Administration to be used to prevent HIV.

The US Food and Drug Administration (USFDA) issued a Form-483 with eight observations concerning manufacturing practices at Sun Pharma’s Halol facility in Gujarat.

The FDA Form 483 does not, however, constitute a final ruling from the agency on whether the conditions are violating any of their regulations.

According to a regulatory filing by the company, the US FDA conducted a Good Manufacturing Practices (GMP) inspection at the Halol site from June 2 to June 13, 2025.

Enhance your regulatory compliance skills with a comprehensive course on FDA regulations for biologics and drug development. Learn practical applications for ensuring compliance with the FD&C Act and ...

Sun Pharmaceutical Industries faces scrutiny. The USFDA issued a Form 483. This follows an inspection of its Halol manufacturing plant in Gujarat. The inspection occurred between June 2 and June ...

The DAP facility consisted of a 480 square feet, two room suite with an office space and a separate, unclassified production ...