USV Private Limited CGMP Violations

A 4/7-4/17 FDA inspection at the USV Private Limited drug manufacturing facility in Dabhel, Daman, Dadra and Nagar Haveli and Dam, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/2 Warning Letter says the specific violations were:

·         failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization practices;

·         failure to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups, and failure to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance; and

·         failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

The letter says USV’s quality systems are inadequate and that executive management should immediately and comprehensively assess the company’s global manufacturing operations to ensure that its systems, processes, and products conform to FDA requirements.

The agency acknowledges that USV suspended production of redacted drugs at the facility for the U.S. market and later indicated its decision to discontinue the commercial manufacturing of products from a redacted filling line for the U.S. market. It asks USV to clarify whether it intends to resume manufacturing drugs for the U.S. market at this facility in the future. It says the company should engage a qualified consultant to perform a six-system audit of its entire operation for CGMP compliance, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of its corrective and preventive actions before USV pursues resolution of its FDA compliance status.

USV was told to promptly address the violations and ensure that appropriate resources are allocated to fully address them and prevent their recurrence.