To allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint
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Task Description Request Please post to the 2015 Pharmacy Inspections and Related Records page.
Record Date 05/22/2015
FEI Number 3003718003
Firm Name Essential Pharmacy Compounding
Record Type 483
State NE
Establishment Type Producer of Sterile Drug ProductseCTD Submission Standards for eCTD v3.2.2 and Regional M1
eCTD Submission StandardsIBSPOT.com Inc. – 715657 – 10/27/2025
Unapproved New Drugs/MisbrandedGFA Production (Xiamen) Co., Ltd. Issues Voluntary Nationwide Recall of Easy Care First Aid® Burn Cream and First Aid Kits Due to Microbial Contamination
Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall is to the consumer level. FDA analysis found the p