FDA issues warning letters to drug manufacturers in India, China and US over GMP violations

The FDA has sent formal warning letters to several companies located in India, China and the United States.

The letters cite multiple breaches of current good manufacturing practice standards in the production of active pharmaceutical ingredients and finished drug products.

The agency said the violations could affect product quality and patient safety, and it expects the firms to take corrective actions promptly.

Companies will need to submit detailed remediation plans and may face further enforcement if issues are not resolved.