FDA 483 - FLOWCHEM PHARMA PRIVATE LIMITED - September 12, 2025

Flowchem Pharma Private Limited, a drug substance manufacturer in Hindupur Taluk, India, was inspected by the FDA from September 8-12, 2025. The inspection revealed significant deficiencies across multiple areas, including inadequate equipment maintenance, unvalidated analytical methods, deficient specifications, improperly qualified standards, incomplete batch records, inadequate process validation, and improper material storage. These issues indicate a broad lack of control over manufacturing processes and quality, suggesting a high severity of non-compliance with GMP regulations.