FDA WARNING_LETTER - Rxhomeo Private Limited - February 01, 2019

The FDA issued a Warning Letter to Rxhomeo Private Limited in Hyderabad, India, following an inspection from January 28 to February 1, 2019. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR, parts 210 and 211), rendering the firm's drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key violations included the firm's failure to test incoming components for identity, purity, strength, and quality, and to validate supplier test analyses, especially for potentially toxic ingredients. The firm also failed to prepare complete batch production and control records, lacking critical details such as equipment identity, component weights, and in-process test results. Furthermore, the quality control unit failed to adequately exercise its responsibility, demonstrating a lack of independence from manufacturing operations and insufficient oversight, including inadequate label release and supplier qualification. The FDA deemed the firm's responses inadequate, noting a failure to assess the impact of deficiencies on marketed products and a lack of detailed corrective action plans. The FDA strongly recommended engaging a qualified CGMP consultant. As a result, the firm was placed on Import Alert 66-40, and the FDA may withhold approval of new applications or refuse admission of products into the U.S. The firm must respond within 15 working days with corrective actions.