CGMP/Finished Pharmaceuticals/Adulterated
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Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension.ByHeart Inc. dba BlendHouse Allerton. Allerton, IA. EIR issued 06/28/2023
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/28/2023
Short Title (70 char) ByHeart Inc. dba BlendHouse Allerton. Allerton, IA. EIR issued 06/28/2023
FEI Number 1921383
Firm Name ByHeart Inc. dba BlendHouse Allerton
Record Type EIR
State IA
EstablishmentUltra Seal Corporation – 624650 – 09/25/2024
CGMP/Finished Pharmaceuticals/AdulteratedEducational Resources
Educational ResourcesLOVION Chocolate with Ginseng for Men may be harmful due to hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use LOVION Chocolate with Ginseng for Men, a product promoted and sold for sexual enhancement on various websites, including lovionusa.com, and possibly in some retail stores.Revive Rx LLC dba Revive Rx Pharmacy – 709509 – 09/22/2025
Compounding Pharmacy/Adulterated Drug Products
