In April this year, the United States Food and Drug Administration (US FDA) had conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility of Time-Cap ...

The US FDA conducted a good manufacturing practices inspection at the Halol facility from June 2-13, 2025, the Mumbai-based drug maker said in a regulatory filing.

Capricor Therapeutics (CAPR) announced the completion of the Food and Drug Administration’s pre-license inspection of its San Diego manufacturing facility for Deramiocel, the company’s lead cell ...

Hyderabad: Granules India has announced that the U.S. Food and Drug Administration (US FDA) has issued one 483 observation ...

Natco Pharma received a Form 483 with seven observations from the USFDA after an inspection in Hyderabad. Conducted from June ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

Granules India's subsidiary resolves FDA observation during inspection at Virginia facility, parent company confirms in filing.

Capricor Therapeutics' rating was downgraded amid FDA inspection risks, regulatory uncertainty, and potential delays in approval for deramiocel. Read more on CAPR stock here.

The FDA issued a warning letter on Nov. 18, 2024, to Breadbox Co., following an inspection from May 10 to June 7, 2024, at its RTE bakery product manufacturing facility in Santa Fe Springs, CA.

Natco Pharma's Kothur facility receives seven observations from U.S. FDA, committed to addressing and maintaining ...

Hyderabad: Natco Pharma Limited has announced that the U.S. Food and Drug Administration (FDA) has concluded an inspection ...

USFDA issued a Form 483 with seven observations to Natco Pharma's Hyderabad facility after an inspection. Natco Pharma is ...