FDA Hits Global Calcium with Major Warning After Plant Inspection

Global Calcium, a producer of active pharmaceutical ingredients, has encountered issues with FDA inspectors following a recent review of its manufacturing plant in Tamil Nadu, India. The inspection, which took place from July 29 to August 2, resulted in the FDA issuing a Form 483 with six significant observations. The detailed but heavily redacted report, released online by the FDA on Wednesday, highlights various production deficiencies, including incomplete batch records, inadequate adherence to manufacturing procedures, insufficient testing practices, and poor facility maintenance.

Global Calcium specializes in high-purity APIs, including those for specialty drugs, psychotropics, antipsychotics, and ophthalmic uses. Their ingredients are used in a range of medications, including antipsychotics, antifungals, antidepressants, hypertension treatments, and anti-inflammatory drugs. The primary concern raised by the FDA pertains to the company’s questionable production documentation.

The company’s production manager admitted to investigators that he instructed staff to fabricate batch records and related documents, such as cleaning and equipment usage logs, for activities that never actually took place, according to the FDA. The agency also discovered discrepancies in the records, noting that a specific batch of API intended for the U.S. was not subjected to required quality assurance testing before shipment.

Additionally, the FDA criticized Global Calcium for mishandling important document issuance and control procedures. The company also failed to implement a continuous testing program to track the stability of its APIs during the inspection. The FDA found that some stability samples, which should have represented commercial products distributed to the U.S., were missing and could not be located.

The FDA also reported that Global Calcium did not set appropriate impurity profiles for APIs destined for the U.S. market and neglected to maintain its facility and equipment adequately, risking contamination of its drug ingredients. Additionally, the FDA noted that the company failed to address deviations in batch records properly and did not investigate the production inconsistencies that arose.