CGMP/Finished Pharmaceuticals/Adulterated
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Institutional Review Board (IRB) Written Procedures
Guidance for institutions and IRBs on IRB written proceduresTopical Antiseptic Products: Hand Sanitizers and Antibacterial Soaps
This page outlines the deferral requests and advice letters issued by FDA to manufacturers of over-the-counter (OTC) topical antiseptic products. These products are categorized as either consumer or health care and they include rubs and washes.BlendHouse Allerton LLC. Allerton, PA. 483 issued 02/20/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 02/20/2025
Short Title (70 char) BlendHouse Allerton LLC. Allerton, PA. 483 issued 02/20/2025
FEI Number 1921383
Firm Name BlendHouse Allerton LLC
Record Type 483
State PA
Establishment Type ManufacturerMiddlefield Original Cheese Co-Op Recalls Organic Gouda, Colored Cheddar, Mozzarella/Provolone, Pepper Jack, Swiss, Dilly Pickle Cheese and Monterey Jack Due to Possible Listeria Monocytogenes Contamination
Middlefield, OH 9/5/25 – The Middlefield Original Cheese Co-Op facility in Middlefield, OH is recalling one lot of Sunrise Creamery Dilly Pickle Monterey Jack Cheese with Dill Pickles in 6 oz. and 1.25 lb. packages, one lot of Organic Gouda Cheese in 8 oz. packages, and specific lots of Mozzarella/PAurobindo Pharma Ltd. Unit-XII – 09/5/2025
Aurobindo Pharma Ltd. Unit-XII – 09/5/2025. Country: India. Record Type: 483ByHeart 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
Establishment
