Megafine Pharma Ltd’s Vapi, Gujarat plant was found to have significantly violated current good manufacturing practice (cGMP) following an inspection by the US Food and Drug Administration (FDA) in September last year.
Among the issues cited in the letter dated February 24 , Megafine’s quality unit had approved the use of adulterated materials to make active pharmaceutical ingredient (API) intermediates.
“Our investigators found that you sourced material from a facility on FDA Import Alert 66-40 for failure to meet CGMP requirements,” the FDA said.
Details of the facility in question were redacted by the Agency.
“The (b)(4) facility has been on FDA Import Alert 66-40 since (b)(4), and was issued Warning Letter (b)(4) stating that (b)(4) API are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act. In addition, you used the (b)(4) site to store and test stability samples.”
Among the facilities under FDA’s Import Alert 66-40 – ‘Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs’ – is Megafine’s API manufacturing plant in Nashik.
The Nashik facility was subject to its own warning letter last May , after the FDA cited details of stability data falsification.
The latest warning letter also cited issues with data integrity at the Vapi plant:
“Your quality assurance unit provides analysts with blank controlled document forms that have already been approved and signed. Investigators observed torn, partially complete QA-signed calibration records in the trash and observed QA staff shredding documents without recording the identity or the reason for shredding the documents.”
Other significant deviations included failings in following cleaning procedures, and inappropriate test methods for demonstrating the purity of drugs made at the site.
“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the FDA said, before setting out a list of actions for Megfine to complete in response to the letter.
These include providing the FDA with a comprehensive investigation into the extent of the inaccuracies in data records and reporting and a risk assessment of the potential effects of the observed failures on the quality of products.