FDA 483 - JKR Pharmacy Ventures, LLC - December 03, 2025

During an FDA inspection from December 3-19, 2025, JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy, a producer of sterile and non-sterile animal drug products, received an FDA Form 483. This document outlined significant concerns regarding the firm's adherence to good manufacturing practices. Key issues included deficient environmental and personnel monitoring systems in aseptic processing areas, with inadequate sampling frequency, action limits, and a lack of dynamic testing. The firm's aseptic and sterilization processes lacked proper validation, as evidenced by media fills not simulating actual production conditions, incomplete documentation, and unvalidated sterilization equipment. Additionally, the pharmacy failed to conduct smoke studies under dynamic conditions and ensure appropriate personnel gowning. Critical written procedures were absent, specifically for separating multiple batch preparations, post-filtration testing, and comprehensive receipt and testing of components, including microbiological testing for purchased water. These observations necessitate the implementation of robust corrective actions to ensure the quality and sterility of manufactured drug products.