The US regulator added Phalanx to its import alert list – also known as the Red List - on Wednesday and suggested the firm’s refusal to allow an agency team to visit its site could indicate manufacturing operations are not up to code.
“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.”
The facility – identified as Plot No.74B – produces 15 active pharmaceutical ingredients (API) – including those for erectile dysfunction drugs, ulcer medications and anticoagulants – and chemical intermediates according to the privately-owned firm’s website.
The site also provides contract manufacturing services for APIs and chemical intermediates.
At the time of publication, Phalanx's websites states that its manufacturing operations comply with “regulatory requirements of various prominent international regulatory bodies, including Europe and US.”
The firm also states the plant is ISO 9001-2008 compliant, accredited by Japan’s Ministry of Health, Labour and Welfare (MoH) and the WHO and has been issued with “written confirmation” of quality needed to ship APIs to the European Union.
Phalanx did not respond to a request for comment.