Warning Letter to Indian API Manufacturer: Batch Release After Fire Incident

During an inspection in September 2024, the FDA identified serious violations of GMP requirements for the manufacture of active pharmaceutical ingredients (APIs) at an Indian facility. Particular focus was placed on the release of API batches affected by a fire and on deficiencies in the stability program.

1. Release of Fire-Affected API Batches

The FDA criticized that several API batches were released and exported to the U.S. despite being impacted by a fire in December 2022. The affected products had been stored in warehouse areas directly impacted by the fire and associated extreme conditions (e.g., heat, smoke). The company's Quality Unit (QU) released the affected batches and failed to initiate recalls, despite internal documentation identifying the impact of the fire. The retrospective assessment carried out by the firm was deemed inadequate by the FDA. According to the FDA, drugs that have been exposed to such uncontrolled conditions are considered adulterated and may not be released for the U.S. market. Furthermore, the manufacturer did not commit to taking action on additional batches previously released but identified as "impacted" in the incident report. The FDA also refers to its guideline on handling drug products or components exposed to improper storage conditions, for example as a result of natural disasters:

2. Inadequate Stability Program

The FDA also noted that adequate stability data to support retest or expiry dates and storage conditions for the APIs were lacking. Over the past two years, repeated power outages occurred in the stability chambers-some lasting up to 40 hours. The company also lacked data loggers to record temperature and humidity profiles during these outages. Although the manufacturer acknowledged the weaknesses in its stability program and announced studies to assess temperature changes during power failures, a complete study protocol, risk assessment, and measures to ensure electrical supply stability were missing.
The original Warning Letter can be found on the FDA website.