Oct 16, 2015
The US Food and Drug Administration (FDA) on Wednesday added Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma's Nashik site in Maharashtra, India, to a list of foreign manufacturing sites banned from sending products to the US.
Megafine, which was hit with an FDA Form 483 back in May at the site, produces 24 APIs for the US market, including for drugs intended to treat Alzheimer's disease, depression, schizophrenia, multiple sclerosis and overactive bladders. The company also produces the same number of APIs for the EU market, as well as a number of other products for Canada, Australia, Brazil, Mexico and South Korea. The Nashik site, according to the company, has been inspected and approved by regulators including the European Medicines Agency, Japan's Pharmaceutical and Medical Devices Agency, the WHO and others.
The notice on Megafine does not indicate the specific issues that caused the import alert and does not indicate if the company's other manufacturing site in Vapi, India will be impacted.
Form 483
According to a heavily redacted 13-page Form 483, the company was cited for manipulating lab tests, as well as unjustified and unrecorded deviations from written lab mechanisms. The 483 notes that one of the company's quality control (QC) analysts "manipulated" a test chromatogram "by removing the unwanted peak out of the chromatogram and passed off the passing chromatogram as the valid result."
In addition, the FDA inspector found that the QC management could not explain the "wide variation between" an initial test result and a retest result, though, “It is believed that the initial OOS [out of specification] assay was switched with old passing sample vials and retested to obtain the passing test results."
Another QC analyst was cited for manipulating high-performance liquid chromatography software "to obtain passing test results."
In addition, FDA found that no "investigation reports were initiated after identification of non-cGMP [current good manufacturing practice] practices within the production and quality control department."
Companies on the import alert list that would like to request removal, according to FDA, "should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. This may include a letter detailing its corrective actions, accompanied by documentation."
Forty-five other Indian pharmaceutical and API manufacturers are currently included on the import alert list, including Ranbaxy, Wockhardt and Ipca Laboratories.
Megafine did not respond to a request for comment.
Source: Regulatory Focus