FDA 483 - Malladi Drugs & Pharmaceuticals Ltd. Unit 1

Malladi Drugs & Pharmaceuticals Limited in Ranipet, India, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to conduct thorough OOS investigations, implemented process changes without formal control, and exhibited inadequate process validation. Additionally, the facility had contamination risks, poor equipment maintenance, and inaccurate raw material records, indicating a broad lack of GMP compliance.