Active pharmaceutical ingredient maker Global Calcium has run afoul of FDA investigators on the heels of a recent inspection of the company’s factory in the Indian State of Tamil Nadu.
Following an inspection that ran from July 29 to Aug. 2, the FDA handed Global Calcium a six-observation Form 483. The heavily redacted document was posted online by the U.S. regulator on Wednesday.
The FDA’s writeup covers an array of production infractions, ranging from incomplete batch records and poorly followed manufacturing procedures to subpar testing and poor facility upkeep.
Global Calcium makes high-purity active pharmaceutical ingredients (APIs), including specialty drug ingredients, psychotropic ingredients, antipsychotic ingredients and ophthalmic ingredients, the company says on its website. Global Calcium’s ingredients are used to make antipsychotics, antifungals, antidepressants, hypertension drugs, inflammatory meds and more, according to the website.
The FDA’s first complaint in the Form 483 comes down to Global Calcium’s questionable production records.
For starters, the company’s production head told investigators that he directed employees to create batch records and supporting records—including cleaning and equipment use logs—for actions that “did not actually occur,” the FDA said.
The FDA found inconsistencies in the records, as well, with the agency noting in its writeup that Global Calcium had failed to submit a certain U.S.-bound API batch for quality assurance testing prior to sending off the ingredient lot.
The FDA also chided Global Calcium for failing to follow procedures around the issuance and control of key documents. Moreover, Global Calcium failed to implement an ongoing testing program to monitor the stability of its APIs at the time of the regulator’s site visit, according to the FDA filing.
The FDA was unable to locate certain stability samples for a number of APIs, which the regulator confirmed were representative of commercial products distributed to the U.S. market.
Global Calcium also failed to establish acceptable impurity profiles for U.S.-market APIs and did not keep its facility and equipment in a state of proper maintenance to prevent contamination of its drug ingredients by other materials, the FDA said.
The investigators’ final complaint came down to undocumented batch record deviations, and Global Calcium’s failure to investigate the production inconsistencies.