The U.S. Food and Drug Administration (US FDA) has issued a Warning Letter to Almon Healthcare Private Limited, Ahmedabad, Gujarat, after identifying significant violations of Current Good Manufacturing Practice (CGMP) regulations at its active pharmaceutical ingredient (API) manufacturing facility during an inspection conducted from February 9–13, 2026. The warning letter was issued on July 13, 2026.
According to the FDA, investigators observed multiple serious deficiencies, including:
• Acceptance of mislabeled incoming raw materials without adequate investigation.
• Failure of the Quality Unit to ensure compliance with CGMP requirements.
• Use of analytical test methods that were not scientifically validated.
• Inadequate equipment cleaning procedures and lack of cleaning validation to prevent cross-contamination.
• Deficiencies in documentation and quality oversight systems.
The FDA stated that because of these unresolved quality concerns, products manufactured at the facility were placed on Import Alert 66-40 in June 2026, allowing U.S. authorities to detain shipments without physical examination until the company demonstrates sustained compliance.
In the warning letter, the FDA asked Almon Healthcare to conduct a comprehensive review of its manufacturing operations, strengthen its quality management system, validate analytical methods and cleaning procedures, and submit a detailed corrective and preventive action (CAPA) plan. Failure to adequately address the deficiencies could result in further regulatory action.
