India’s Megafine Pharma has received its second FDA warning letter in 10 months, this one for an API intermediates plant in India.
The FDA issued a warning letter for the Megafine plant in Vapi, Gujarat, last month and posted it Tuesday. It followed an inspection at the plant last September.
The agency had banned a Megafine API plant in Lakhmapur, Nashik, in 2015 and then followed that up with a warning letter in May of last year.
The FDA outlines a host of problems at the intermediates plant, including faking data, an issue that was front and center in the problems the FDA noted at the Nashik plant. In fact, the FDA said the facility was “issuing analysts with blank controlled document forms that had already been approved and signed.”
Investigators also found partially completed QA-signed calibration records in the trash and saw QA staff shredding documents without any record of why.
The FDA asked for a complete assessment of what effects the data irregularities caused and said Megafine could even reference the first warning letter it received for an idea of what the agency expects.
Investigators also found that the plant had sourced materials for some of its products from an unnamed company whose plant the FDA said was banned from shipping to the U.S. and which itself is the subject of an FDA warning letter. To top it off, the Megafine facility had dirty equipment.
It is not all that surprising for a company to get a second or third FDA citation in fairly rapid succession these days since the FDA often moves on to other facilities for those companies where it discovers what seem to be systemic issues.
India's Wockhardt, which had two plants banned in 2013 because of data integrity and other issues, has since received five warning letters in the last three years, including for plants in the U.K. and just this month, in the U.S. It was also issued an untitled letter in January for its new sterile injectables manufacturing plant in India for which it is seeking FDA approval.
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The FDA has also put more attention on Indian as well as Chinese facilities, which produce most of the ingredients for drug manufacturers in the U.S., and where it figures risks are greater.
In fact, the FDA has just announced a long-proposed agreement with the European Medicines Agency to recognize the inspections that each agency does in their respective jurisdictions. That means except in special circumstances, FDA inspectors will no longer need to check out plants in the EU, freeing up more time and resources to concentrate on those areas where they believe the risks of manufacturing irregularities are greater. That arrangement is slated to kick in Nov. 1 of this year.