Global Calcium, an active pharmaceutical ingredients (APIs) producer in Tamil Nadu, India, has come under scrutiny from the FDA following an inspection of its facility.
The inspection, conducted between July 29 and August 2, 2024, resulted in the issuance of a Form 483, citing six observations of non-compliance with FDA regulations. One of the most alarming findings was the admission by the production head that batch records and related documentation were created for processes that never actually took place.
Additionally, the FDA identified discrepancies in these records and pointed out that a batch of API destined for the U.S. had been shipped without undergoing the required quality assurance testing.
The agency also raised concerns about Global Calcium’s document management practices, noting that the company failed to establish a continuous testing program to ensure the stability of its APIs. During the inspection, FDA officials were unable to locate stability samples for multiple APIs that were already being sold in the U.S., further questioning the reliability of the company’s quality control measures.
Moreover, the FDA report criticized the company for not maintaining an acceptable impurity profile for its U.S.-market APIs and for failing to keep its facility and equipment in proper condition to prevent contamination. The lack of documented investigations into deviations in batch production was another major issue flagged by the FDA, indicating potential risks in the consistency of their product output.
According it its website, Global Calcium manufacturers over 150 products, shipped to over 65 countries, and specializes in APIs such as antipsychotics, antifungals, antidepressants and antibacterials.
