API manufacturer Global Calcium has been struck with a Form 483 filing following an FDA inspection of its factory in India.
Between 29 July and 2 August 2024, the agency inspected Global Calcium’s manufacturing site in the Indian State of Tamil Nadu, raising concerns.
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The manufacturer, which is FDA and EU good manufacturing practice (GMP)-approved, makes specialty APIs for psychotropics and antipsychotics. It also manufactures mineral salts and premixes for pharmaceutical, nutritional, food and other applications, as per the company website.
The FDA report, which is heavily redacted, cited concerns including incomplete batch records, lack of procedures for issuance and document control, insufficient maintenance of equipment and inadequate impurity profiles for APIs meant for the US market.
In the first complaint, the FDA stated that the production head and plant manager were involved in falsifying production records. They directed employees to create batch records, cleaning records, and equipment logs for activities that “did not actually occur”, said the FDA. The plant manager used Microsoft Excel to generate fake production plans, which employees followed to fabricate the records.
On 29 July 2024, the fake plans were found attached to blank batch records in the production office. The production head deleted relevant Excel files from the plant manager’s computer that evening, hindering the inspection.
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By GlobalDataIn another query, the quality assurance group issued duplicate logs that were used to create false records. Both sets of conflicting records were reviewed and approved. Additionally, the lab kept uncontrolled notebooks with critical measurements including assay results, limit of detection, pH levels and sample weights. These were later copied into official reports, leading to discrepancies in product documentation.
In June 2024, China-based Jiangsu Hengrui was also hit with a Form 483 following an inspection of its manufacturing site in the Chinese city of Lianvungang, Jiangsu province. The company, which produces anti-tumour drugs and antibiotics, was cited for inadequate procedures to prevent microbiological contamination in its products claiming to be sterile. The inspection found that the facility’s aseptic and sterilisation processes were not adequately validated.
