FDA WARNING_LETTER - Malladi Drugs & Pharmaceuticals Ltd. - September 08, 2017

The FDA inspected Malladi Drugs & Pharmaceuticals Limited, Unit 1, in Ranipet, India, from September 4 to 8, 2017, and found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated under section 501(a)(2)(B) of the FD&C Act. Key violations include the failure to use appropriate precautions to minimize API contamination, as evidenced by vermin near open equipment, and the failure to have equipment of appropriate design and suitability for its intended use and cleaning, specifically regarding the use of (b)(4) vessels and insufficient cleaning processes. Additionally, the firm failed to demonstrate that its manufacturing process can reproducibly manufacture an API meeting predetermined quality attributes, citing inadequate process validation, lack of control during a specific step, numerous out-of-specification batches, and process changes initiated without formal change management. The FDA recommended engaging a CGMP consultant and placed the firm on Import Alert 66-40 on December 13, 2017. The company must provide risk assessments for potentially contaminated or inappropriately manufactured drugs, commit to replacing unsuitable equipment, and submit a data-driven process validation program, along with comprehensive evaluations and remediation plans for their change management and CAPA systems. A written response detailing corrective actions is required within 15 working days, with potential consequences including withheld approvals and continued refusal of admission for products into the U.S.