June 2, 2014
Ms. Francisca Trevino Rivas
Avenidade Antibioticos 59-61
Leon, Spain 24009
Dear Ms. Rivas,
The owner of the above referenced facility has failed to self-identify the facility and pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 2012 (GDUFA). See 21 U.S.C. §§ 379j-41 to 379j-42.
GDUFA defines a facility in relevant part as "a business or other entity ...at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form. "21 U.S.C. §§ 379j-41(5)(A)(i). If such a facility is identified or intended to be identified in a pending or approved generic drug submission, the person that owns that facility must submit information concerning the facility to FDA (self-identify) each year in accordance with 21 U.S.C. § 379j-42(f). Self-identification for fiscal year 2013 was required on or before December 3, 2012 and self-identification for fiscal year 2014 was required between May 1, 2013 and June 1, 2013.
If such a facility is identified or intended to be identified in a pending or approved generic drug submission on the facility fee due date, the person that owns that facility must pay an annual facility fee. 21 U.S.C. § 379j-42(a)(4). The fees for fiscal year 2013 were due on March 4, 2013 and the fees for fiscal year 2014 were due on October 18, 2013. Only facilities that manufacture positron emission tomography drugs are exempted from this and other GDUFA fee requirements. See 21 U.S.C. § 379j-42(1).
Any drugs or active pharmaceutical ingredients (API) manufactured, prepared, propagated, compounded, or processed at a facility for which required facility fees have not been paid or required self-identifying information has not been submitted, or drugs containing an active pharmaceutical ingredient manufactured, prepared, propagated, compounded, or processed at such a facility are misbranded. 21 U.S.C. §§ 352(aa), 379j-42(g)(4)(A)(iii). It is a violation of federal law to ship misbranded products in interstate commerce, which includes causing such products to be imported into the United States. 21 U.S.C. § 331(a). Such violations can result in injunctions or seizures of the misbranded products. See 21 U.S.C. §§ 332 and 334. Products that appear to be misbranded may also be denied entry into the United States. 21 U.S.C. § 381(a)(3).
Facilities that fail to pay the annual facility fee are placed on a publicly available GDUFA facility arrears list. 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 within the meaning of 21 U.S.C. § 355G)(5)(A). In addition, any new generic drug submission that references such a facility will not be received, within the meaning of 21 U.S.C. § 355G)(5)(A), if the outstanding facility fee is not paid within 20 calendar days of FDA providing notification to the sponsor of the failure of the owner of the facility to pay the facility fee. 21 U.S.C. § 379j-42(4)(ii).
The above-referenced facility is a drug manufacturing facility as defined under GDUFA. It was identified in a pending and/or approved ANDA on the dates for self-identification for fiscal year 2013 and fiscal year 2014, and on the dues dates for facility fees for fiscal year 2013 and fiscal year 2014. The facility has self-identified for 2013, but has not self-identified for 2014 and has not paid the 2013 or 2014 facility fees as required by GDUFA. Therefore, all finished dosage forms of drugs or APIs, as well as drug containing an API, manufactured at the facility are misbranded.
Your facility has been placed on a publicly available GDUFA facility arrears list for failure to pay required fees in 2013 and 2014. See link to arrears list at: http://www.fda.gov/forindustry%20/userfees/genericdruguserfees/default.htm. Failure to correct these violations promptly may result in regulatory action, including but not limited to seizure or injunction without further notice. Your facility may also be placed on import alert such that any drug the facility manufactures will be refused admission into the United States.
You should take prompt action to correct the violations noted above by immediately self identifying for fiscal year 2014 and paying fiscal year 2013 and 2014 fees. Information, including who is required to self-identify, how the information is submitted to FDA, who is required to pay facility fees, the penalty for failure to self-identify or to pay a facility fee, and the technical specifications for self-identification and fee payment, is available on FDA's GDUFA Web page at www.fda.gov/gdufa.
If, as a result of receiving this warning letter or for other reasons, you are considering a decision that could reduce the number of finished drug products or active pharmaceutical ingredients produced by your manufacturing facility, FDA requests that you contact CDER's Drug Shortages Program immediately, as you begin your internal discussions, at firstname.lastname@example.org, so that we can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Program also allows you to meet any obligations you may have to report discontinuances in the manufacture of your drug under 21 U.S.C. 356C(a)(1), and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. In appropriate cases, you may be able to take corrective action without interrupting supply, or to shorten any interruption, thereby avoiding or limiting drug shortages.
This letter is not intended to identify all of the ways in which your activities might be in violation of law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations.