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Regulatory Focus™ > News Articles > 2019 > 10 > FDA Warns Indian, Bahamian Drugmakers

FDA Warns Indian, Bahamian Drugmakers

Posted 15 October 2019 | By Michael Mezher 

FDA Warns Indian, Bahamian Drugmakers

The US Food and Drug Administration (FDA) earlier this month sent warning letters to Indian drugmakers Glenmark Pharmaceuticals and Torrent Pharmaceuticals and Bahamian drugmaker Coral Pharmaceuticals over good manufacturing practice (GMP) violations at their facilities.
In its warning letter to Glenmark Pharmaceuticals, FDA cites the company for failing to adequately investigate multiple complaints, out-of-specification (OOS) test results and temperature discrepancies during shipping for products made at its Himachal Pradesh facility.
According to the warning letter, Glenmark received at least 38 complaints and rejected 20 batches of a topical drug due to complaints about grittiness. FDA says that product grittiness has been an “ongoing formulation issue” and resulted in a citation during the agency’s previous inspection of the facility in 2010.
While Glenmark told FDA that the grittiness issue was addressed in a reformulation in 2018 and recalled all batches of the product within expiry made using the original formulation, the agency says the company “did not provide sufficient data to demonstrate the robustness of the new formulation.”
FDA also says that Glenmark distributed batches of a topical cream that were exposed to temperature excursions during shipping, also a repeat issue from the previous inspection, and failed to adequately investigate OOS test results for some of its products.
Additionally, FDA says the company failed to adequately investigate more than 70 consumer complaints of punctures, cracks and holes in the container/closure system for some of its products. While the company determined the root cause of these issues to be improper handling by consumers, FDA says the company “closed more than 50 of the complaints, without [corrective and preventative action] CAPA to prevent recurrence of similar quality defects.”
FDA’s warning letter to Torrent Pharmaceuticals comes after a nine-day inspection of the company’s Gujarat facility last April uncovered issues with the company’s testing procedures and OOS investigations for its Losartan Potassium tablets.
Torrent has been one of several companies to recall drugs as part of an ongoing global investigation into nitrosamine impurities in angiotensin II receptor blockers (ARBs) such as valsartan, losartan and irbesartan. 
According to FDA, Torrent’s internal procedures require quality attributes to be met for three consecutive batches to qualify an alternate active pharmaceutical ingredient (API).
However, FDA says the company failed to follow these procedures after introducing a new alternate API for its 50 and 100mg Losartan Potassium Tablets. Instead, after four consecutive batches failed the company’s process validation protocol, it “developed a new interim protocol to justify commercial use of the alternate API and circumvented [its] original protocol.”
FDA says multiple batches of Losartan tablets were manufactured and distributed to the US despite the process validation issues, noting that some of those batches were recalled “for unacceptable amounts of nitrosamine impurities.”
FDA also says it found multiple instances where Torrent improperly invalidated OOS results and “has a high percentage rate (60-70%) for invalidated initial OOS test results” from January 2017 to March 2019.
In its warning letter to Coral Pharmaceuticals, FDA cites the firm for product testing and quality control issues related to a homeopathic drug the company manufactures at its Freeport City facility on Grand Bahama island.
According to FDA, Coral manufactured and distributed the homeopathic product, which is “derived from a toxic ingredient,” without having data to support that the product is produced at the concentration specified on its label.
FDA says that Coral then contacted the customer it manufactures the homeopathic product for information about the product’s concentration, which turned out to be “orders of magnitude” greater than the concentration stated on the label.
“You did not know the true concentration of the homeopathic drug product you distributed, which is especially concerning as it contains [a] toxic ingredient,” FDA writes.
FDA also says the company failed to conduct identity testing on a product component containing a toxic ingredient prior to its use and failed to establish an adequate quality control unit.
As a result of these issues, FDA placed Coral on Import Alert last month, noting in the warning letter that the firm has indicated it is no longer manufacturing products for the US market and is unlikely to do so in the future.
Warning Letters: Glenmark, Torrent, Coral

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