India Facility Receives Warning Letter

FDA sent a warning letter, dated Dec. 17, 2019, to GPT Pharmaceuticals Private Ltd after an inspection of the company’s Hyderabad, India facility found violations of current good manufacturing practice (CGMP) that ranged from failures in quality control, equipment maintenance, and data integrity.

In the letter, FDA stated that the company’s quality unit had not properly investigated out-of-specification test results for residual solvents, did not validate test methods for assay and impurities, and did not ensure adequately recorded and reported documentation. The agency requested the company provide an assessment and remediation plan to ensure its quality unit effectively functions.

The company also failed to properly maintain equipment, according to the agency. “Our investigator observed that your dedicated equipment such as the (b)(4) and (b)(4) used to manufacture (b)(4) had visible rust, dents, and scratches on product contact surfaces,” the letter stated. FDA requested the company provide a corrective action and preventive action plan (CAPA) for operations management oversite of its facilities and equipment, as well as a CAPA for a retrospective assessment that includes remediations to cleaning processes and practices.

In addition, the company was cited for lacking appropriate controls over laboratory equipment. “Your employees used the Agilent Service Account login, with full administrative privileges, to abort HPLC testing runs without being attributable to a specific individual,” the letter stated. The agency requested the company provide an investigation into data inaccuracies, a risk assessment of potential effects on product quality, and a management strategy for a global CAPA to ensure data integrity.

In response to the CGMP violations, FDA placed the company on Import Alert 66-40 on Dec. 16, 2019. “Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer,” the agency stated in the letter.

Source: FDA