FDA 483 - USV Private Limited - September 12, 2025

USV Private Limited, an Active Pharmaceutical Ingredient (API) manufacturer in Takula Khed, Maharashtra, India, underwent an FDA inspection from September 8 to September 12, 2025. This inspection resulted in an FDA Form 483, identifying an significant observation concerning manufacturing practices.

The main issue highlighted was that equipment and utensils were not cleaned at appropriate intervals to prevent contamination impacting drug product safety, identity, strength, quality, or purity. Specifically, inspectors observed (b)(4) bowls used for API production with substantial residue covering product contact surfaces. While the firm suggested this was equipment discoloration, not product residue, the observation noted the potential for this residue to transfer between batches. Moreover, if the residue originated from the (b)(4) bowls, there is a risk of materials from the equipment's construction leaching into the API material.

This finding indicates a potential deviation from established good manufacturing practices for equipment sanitation and cross-contamination control. USV Private Limited is expected to provide a comprehensive response detailing corrective and preventive actions to ensure thorough equipment cleaning and prevent any potential compromise to product quality or safety.