FDA adds 4 API manufacturers to 'Red List'
Fleming Laboratories Limited, an India-based active pharmaceutical ingredient (API) manufacturer, told us the company was previously audited by European Authorities (EDQM and EUGMP) in 2010 and 2013.
According to the company, Fleming failed the audit and all certificates of suitability (CEPs) filed were withdrawn, after which the US FDA put an Import alert on the Fleming Labs facility/company.
Satish Kalidindi at Fleming Labs told us that there has been a management change at the company since the audit failure, and Mr. Jeyamuruga Prakash is the new CEO & managing director.
Kalidindi explained, “There has been new developments initiated by the new management for the restructuring of the Company on various fronts with priority to GMP compliance.”
Fleming has resubmitted several CEPs, after which the company was re-audited by EDQM and EUGMP (Italian agencies) during November 2015 for the API Cinnarizine.
Kalidindi told us, “The outcome of the audit was ‘Fleming Laboratories was found in compliance with EUGMP.’”
After receiving the EUGMP certificate, Fleming has requested that the US FDA remove the Import Alert.
Kalidindi told us that the company’s consultants in the US are in the process of discussion with the USFDA on the Import alert withdrawal. “We hope to close the Import Alert issue with the USFDA very soon,” he added.
Fleming Labs is among one of the four companies to be recently added to the FDA’s “Red List.”
The FDA has also added Jiangsu ZW Pharmaceuticals, Wuxi Kaili Pharmaceutical Company, and Sharon Bio-Medicine Limited.
According to the FDA, “The Red List of this Import Alert identifies certain facilities whose owners are not in compliance with the fee payment or self-identification requirements of GDUFA and that have imported or offered for import drugs or active pharmaceutical ingredients.”
The Import Alert explained that the facility owners were notified individually that they were in violation of the Act and that their products would be “subject to refusal of admission because they appear to be misbranded.”
All four companies had previously received warning letters (see here, here, here, and here).
The Alert said, “The owners of these facilities have not made significant efforts to correct the violations during the time allotted in the communication notifying them of the violation.”