Akron Formulations India Private Limited Warning Letter Details

Summary

Akron Formulations India Private Limited, a manufacturer of over-the-counter drug products, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered its finished pharmaceuticals adulterated. The facility failed to establish an adequate quality control unit with proper authority to approve or reject components, drug products, and materials, and critically, it used active pharmaceutical ingredients from multiple suppliers that were subject to FDA import alerts at the time the products were manufactured and shipped to the United States. These manufacturing and control deficiencies violated Title 21 CFR parts 210 and 211, indicating the company's methods, facilities, and controls did not conform to required standards.