Germany-based CMO CPM Contract Pharma was hit with the first US FDA warning letter for failing to self-identify its manufacturing facility and pay the facility fee required by the Generic Drug User Fee Amendments of 2012.
“Facilities that fail to pay the annual facility fee are placed on a publicly available arrears list,” the FDA said in its warning letter . “Any generic drug submission from the person responsible for paying the fee, or from an affiliate of that person, will not be received by FDA.”
If the fees remain unpaid, all finished dosage forms of drugs or APIs (active pharmaceutical ingredient), as well as drug containing an API, manufactured at the facility will be considered misbranded and not allowed on the market.
But the agency also says that “because the fiscal year 2014 self-identification reporting period has begun, you will be unable to self-identify for fiscal year 2013,” though the agency “will not take enforcement action against you or your products for failure to self-identify for fiscal year 2013 if you complete your 2014 self-identification submission within 15 working days of receipt of this notice,” according to the Sept. 17 letter.
The fees for fiscal year 2013 were due on March 4, 2013 and a foreign generic drugmaker like CPM was required to pay more than $190,000 to register . Only facilities that manufacture positron emission tomography drugs are exempted from this and other GDUFA fee requirements.
For 2014, foreign generic drugmakers will see a more than $40,000 increase in the facility fees that will be required to pay.
According to its website, CPM focuses on semi-solid, liquid and solid manufacturing, as well as packaging. CPM did not respond to a request for comment.