The US Food and Drug Administration (FDA) has issued a warning notice to Brassica Pharma's Thane-based facility following an inspection that identified substantial violations of Current Good Manufacturing Practice (CGMP) requirements. The inspection, which took place from January 15 to 19, 2024, at their factory in Tarapur, Boisar, revealed major issues with data integrity, sterility testing, and aseptic processing methods.

In a scathing letter, the FDA highlighted multiple serious violations at Brassica Pharma, including data integrity breaches, insufficient sterility testing, poor aseptic methods, and insufficient cleaning and maintenance processes.

Data integrity violations were common, with insufficient laboratory records and regular falsification of sterility test findings and environmental monitoring results. The only analyst in charge of sterility testing admitted to falsifying documents and not testing all batches. During the inspection period, there were numerous action-level excursions in environmental monitoring, including 37 in the ISO 5 and 17 in the ISO 7 areas. Brassica Pharma's reaction lacked a complete retrospective examination of all recorded data, raising concerns about the accuracy and integrity of data throughout the whole facility.

The drug regulator stated in its letter that it also found the sterility testing to be inadequate. The validation procedure was insufficient, omitting critical processes and materials as well as failing to include all formulas intended for distribution in the United States. The FDA chastised the company's overreliance on sterility testing as the main quality control measure, pointing out that it cannot guarantee batch sterility due to the episodic nature of contamination.

The FDA noted that the facility's aseptic practices were inadequate, stating that its inspectors observed operators touching sterile tubes, leaning over the filling line, and operating with exposed skin in ISO 5 and ISO 7 areas. Gowning practices were insufficient, with discoloured and ripped clothing visible during aseptic procedures. Furthermore, neither the documentation nor the simulation of interventions accurately reflected commercial aseptic production operations in media fill programs.

While cleaning and maintenance methods were equally troublesome, the drug regulator found that cleaning validation was deficient during the inspection, with differences in cleaning frequency and validation techniques. The lack of thorough cleaning and documentation of parts of the aseptic processing lines raised serious concerns about contamination.

The FDA suggested conducting a thorough examination of data inconsistencies, assessing the potential implications of identified failures on medicine quality, and developing a detailed corrective action plan. Brassica Pharma has committed to suspending all medicine manufacturing and distribution in the United States, as well as a voluntary recall of items currently in distribution.

However, the FDA ruled the company's responses to its findings unsatisfactory. The FDA stressed the importance of an independent evaluation of laboratory methods, aseptic processes, environmental monitoring programs, and cleaning validation protocols. The FDA also recommended an impartial third-party expert to examine operations and assist with FDA compliance.

Brassica Pharma's repeating pattern of data fabrication and poor aseptic methods suggests that there are systemic flaws with the company's quality system. The lack of effective answers to FDA observations reveals a concerning gap in CGMP compliance, which is required to assure the safety and efficacy of pharmaceutical goods.

These infractions have serious consequences because they not only jeopardize the quality of drug items but also put patient safety at risk. The FDA is making severe efforts and recommendations to rectify these inadequacies and prevent future occurrences.

The FDA's red flags on Indian pharmaceutical manufacturing units, such as Brassica Pharma, highlight the importance of strict adherence to CGMP requirements. Ensuring data integrity, rigorous sterility testing, and adequate aseptic processes are critical for protecting public health and preserving faith in pharmaceutical production standards.