CGMP/Finished Pharmaceuticals/Adulterated
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BlendHouse Portland LLC. Portland, OR. EIR issued 04/26/2024
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 04/26/2024
Short Title (70 char) BlendHouse Portland LLC. Portland, OR. EIR issued 04/26/2024
FEI Number 3013670080
Firm Name BlendHouse Portland LLC
Record Type EIR
State OR
Establishment Type ManufacturerCSL Behring – 716297 – 09/09/2025
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)Gerber Products Company Announces Voluntary Recall of Limited Batches of Arrowroot Biscuits Out of an Abundance of Caution Due to Potential Presence of Foreign Material Following Supplier Recall
January 26, 2026 — Gerber Products Company is initiating a voluntary recall of limited batches of Gerber® Arrowroot Biscuits out of an abundance of caution due to the potential presence of soft plastic and/or paper pieces that should not be consumed. The material comes from an arrowroot flour suppliANDA Assessment Program | GDUFA III Performance Goals and Program Enhancements
GDUFA III includes several enhancements to the ANDA assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements aim to reduce the number of assessment cycles and facilitate timely access to safe, effective, high-quality, and affordable generics.Center for Biologics Evaluation and Research & Center for Drug Evaluation and Research Real-World Evidence
As defined by FDA, real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources and real-world evidence (RWE) is the clinical evidence regarding a medical product’s use and potential benefits or risks derived frPrivate Label Skin Care, Inc. – 715880 – 12/18/2025
CGMP/OTC/Adulterated/Misbranded