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The US FDA issued a Form 483 observation for its Telangana API facility. While not a final non-compliance verdict, the company plans a timely response. The facility is key for paracetamol API ...

Granules India Ltd.'s active pharmaceutical ingredient facility in Telangana received an observation from the US Food and Drugs Administration under Form 483, according to an exchange filing. The FDA ...

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

Natco Pharma received a Form 483 with seven observations from the USFDA after an inspection in Hyderabad. Conducted from June 9-19, 2025, the inspection pointed out conditions potentially violating ...

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.

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

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.