FDA 483 - ALMON HEALTHCARE PRIVATE LIMITED - February 13, 2026

Aimon Healthcare Private Limited in Ahmedabad, India, received an FDA Form 483 citing significant deficiencies across its operations. The inspection revealed critical failures in the quality unit's oversight, including inadequate document control, lack of proper validation for test procedures, and compromised cleanroom conditions. These issues indicate a systemic breakdown in CGMP compliance, impacting active pharmaceutical ingredients (APIs) shipped to the US market.