Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sharon-bio-medicine-limited-06222015
Timestamp: 2019-06-16 11:47:18
Document Index: 32503369

Matched Legal Cases: ['§ 352', '§ 331', '§ 332', '§ 381', '§ 355', '§ 355', '§ 379']

Sharon Bio-Medicine Limited - 06/22/2015 | FDA
Sharon Bio-Medicine Limited - 06/22/2015
Sharon Bio-Medicine Limited 22/06/2015
WL: GDUFA-15-019
Mr. Sanjay Panday
Khasra 1027/28/30/37
Dehradun Uttarakhand 248197
FEI - 3005925733
Dear Mr. Panday:
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. § 355(j)(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. § 355(j)(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(g)(4)(A)(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 years 2013, 2014, and 2015, and on the due dates for facility fees for fiscal years 2013, 2014 and 2015. The facility has self-identified for fiscal years 2013, 2014, and 2015 but, has not paid the 2013, 2014, and 2015facility 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 fiscal years 2013, 2014, and 2015. Seelink 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 paying fiscal years 2013, 2014, and 2015 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.