FDA WARNING_LETTER - Global Calcium Pvt. Limited - August 02, 2024

The FDA issued a Warning Letter to Global Calcium Pvt. Limited following an inspection from July 29 to August 2, 2024, at their Hosur, India facility, identifying significant CGMP deviations for active pharmaceutical ingredients (APIs), rendering their products adulterated.

Key violations include: 1. **Failure of the quality unit to prepare, review, and approve documents:** Production records showed simultaneous manufacturing of different APIs on the same equipment. Multiple electronic records were deleted during the inspection, which the company admitted was to "avoid unwanted conversation" and that falsified records were created to claim production incentives. The company's response was deemed inadequate, as their quality impact assessment relied on deficient data, and they failed to adequately address the extent of record fabrication or reconcile all CGMP records. 2. **Failure to properly maintain buildings and facilities:** Investigators observed liquid dripping from a ceiling pipe onto processing equipment labeled as clean. The company's response was inadequate, failing to address potential contamination of previously manufactured lots or provide evidence of a comprehensive facility evaluation. 3. **Failure to establish a comprehensive impurity profile:** The company's impurity profiles for APIs were incomplete, only listing USP-described impurities without considering their unique processes. Impurities were also not monitored during stability studies. The company's response was inadequate, as they had received returned products due to quality issues and failed to provide a retroactive risk assessment or communicate updated profiles to customers.

The FDA recommends engaging a