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Regulatory News | 16 June 2016 | By Zachary Brennan
The US Food and Drug Administration (FDA) this week added contract manufacturer Cheryl Laboratories’ Navi Mumbai-based manufacturing facility and active pharmaceutical ingredient (API) and intermediate manufacturer Phalanx Labs’ Visakhapatnam-based site to its list of foreign firms that are banned from shipping product to the US because they refused FDA inspections.
FDA’s “Red List” identifies firm(s) that have offered FDA-regulated articles for import into the US and yet refused to allow the completion of an FDA inspection of their foreign establishments for the purpose of determining establishment conditions and compliance with applicable laws and regulations.
Cheryl Laboratories (the picture at right is from the company’s website), which was added to the list on Monday, has been manufacturing pharmaceuticals, including creams, ointments, gels and antiseptic solutions since 2004.
Phalanx Labs, which was added to FDA’s list on Wednesday, claims on its website that it manufactures APIs and intermediates that comply with “the regulatory requirements of various prominent international regulatory bodies, including Europe and U.S.” The company also says that its quality management system complies with ISO 9001-2008 and that its facility was accredited by Japanese regulators.
Neither company responded to a request for comment.
The companies join three other Chinese pharmaceutical companies that have been added to the list in 2016.
“The refusal to permit inspection of a foreign facility or provide reasonable access to FDA’s inspectional personnel, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions,” FDA says.
Foreign medical device manufacturers have also refused or failed to respond to FDA inspections in recent months.
Import Alert 99-32
Tags: API manufacturing, FDA manufacturing inspections