The US Food and Drug Administration (FDA) last month warned Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma Ltd. over data integrity and manufacturing violations at its Gujarat, India facility.
The warning letter comes after FDA inspected the Gujarat facility over the course of five days last September, and less than a year after the agency warned Megafine for a host of data integrity violations at its other facility in Maharashtra, India that landed the site on FDA's import alert list in 2015.
As in the previous warning letter, FDA cites Megafine for data integrity issues.
According to FDA, the company routinely re-ran purity tests until favorable results were achieved, and did not investigate potential impurities identified in at least three batches of drugs.
"Your Deputy Manager, Quality Control stated that it is common practice to 'play with parameters' to get the proper integration," FDA writes.
Additionally, FDA says Megafine's quality assurance (QA) unit had been handing out pre-approved and signed document forms to its analysts to fill out.
"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," FDA writes.
During the inspection, FDA investigators say they discovered Megafine was using materials sourced from a facility on the agency's import alert list to produce API intermediates.
"Our investigators found that you sourced material from a facility on FDA Import Alert 66-40 for failure to meet [current Good Manufacturing Practice] cGMP requirements," FDA writes. It is unclear whether the facility the materials were sourced from is Megafine's Maharashtra site, as all identifying references to the facility are redacted in the warning letter.
In the company's response to the warning letter, FDA asks that Megafine come up with an action plan to address the use of adulterated material by notifying its customers and recalling any adulterated drugs that have been distributed within the US.
FDA also cites Megafine for failing to establish and follow procedures for cleaning its equipment used to manufacture APIs.
"Our investigators found that the interior surfaces of your drug manufacturing equipment [Redacted], [Redacted] apparatus, and [Redacted] were not clean as required by your procedures. For example, our investigators observed [Redacted] residue and [Redacted] discoloration at the bottom of [Redacted] apparatus BSR-04, although the machine was labeled 'clean.'"