The recent FDA warning letter to an Indian manufacturer of active pharmaceutical ingredients (APIs) highlights major Good Manufacturing Practice (GMP) violations, particularly regarding the handling of fire-affected API batches and significant deficiencies within the company’s stability program[1].
## Regulatory Findings: GMP Breaches
During the FDA’s inspection in September 2024, the agency discovered that multiple API batches stored in warehouse areas directly impacted by a fire in December 2022 were released and exported to the U.S. market[1]. These products had been exposed to severe environmental conditions such as heat and smoke, yet the company’s Quality Unit approved their release without initiating a recall, despite internal records confirming the adverse impact of the fire[1]. The FDA deemed the company’s retrospective assessment inadequate and emphasized that pharmaceuticals exposed to uncontrolled conditions should be considered **adulterated** and are not permissible for U.S. distribution[1]. Additionally, there was no commitment from the manufacturer to address other potentially impacted batches identified in post-incident documentation[1].
## Stability Program Gaps
The FDA also identified severe shortcomings in the manufacturer’s stability program[1]. Over the previous two years, repeated power outages—some lasting up to 40 hours—compromised storage chamber conditions. The absence of data loggers meant temperature and humidity changes during outages were not recorded[1]. While the manufacturer acknowledged these weaknesses and promised further temperature-assessment studies during power failures, there was no comprehensive study protocol, formal risk assessment, or effective measures to stabilize electrical supply — all critical requirements for ensuring GMP compliance[1].
## Regulatory Guidance
The FDA referenced existing guidance documents for handling pharmaceutical products or components exposed to substandard storage conditions, especially as a result of natural disasters or facility incidents[1]. Notably, the agency stressed that failing to adhere to these established protocols threatens drug safety and quality, posing risks to patient health[1].
## Industry Context and Upcoming Events
GMP professionals may benefit from upcoming industry events spotlighting compliant site transfers, granulation & tableting technology, and advanced visual inspection methods. Conferences in Barcelona and Vienna during September–October 2025 will provide in-depth guidance on these topics[1]. Recent related news includes updates to pharmaceutical water standards, cleanroom guidelines, and advances in compaction simulation — all reflecting evolving regulatory expectations for drug manufacturers[1].
This warning letter serves as a strong reminder of the regulatory scrutiny and operational rigor required to maintain global pharmaceutical supply chain integrity and public health[1].
Mr. Achal Agrawal
CEO
Macsen Drugs
F-261, 262, 263 Riico Industrial Area, Gudli
Tehsil Mavli, Udaipur 313024 Rajasthan
India
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