The Knowledge Shelf

US FDA

STAQ Pharma of Ohio, LLC. Columbus, OH. 483 issued 05/16/2025
ByDossier Experts June 23, 2025

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 05/16/2025
Short Title (70 char) STAQ Pharma of Ohio, LLC. Columbus, OH. 483 issued 05/16/2025
FEI Number 3025336457
Firm Name STAQ Pharma of Ohio, LLC
Record Type 483
State OH
Establishment Type Outsourcing Fac

Read More STAQ Pharma of Ohio, LLC. Columbus, OH. 483 issued 05/16/2025
MHRA

Guidance: AI Airlock Background
ByDossier Experts June 23, 2025

Background information for MHRA AI Airlock launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products.

Read More Guidance: AI Airlock Background
MHRA

AI breakthroughs drive expansion of ‘Airlock’ testing programme to support AI-powered healthcare innovation
ByDossier Experts June 23, 2025

MHRA opens second round of applications to test cutting-edge AI medical technologies following successful pilot phase.

Read More AI breakthroughs drive expansion of ‘Airlock’ testing programme to support AI-powered healthcare innovation
MHRA

Guidance: AI Airlock Phase 2 application
ByDossier Experts June 23, 2025

The call for application for phase 2 of the AI Airlock is now open. This page contains information on eligibility and how to apply

Read More Guidance: AI Airlock Phase 2 application
US FDA

October 10, 2024: Meeting of the Cardiovascular and Renal Drugs Advisory Committee – 10/10/2024
ByDossier Experts June 21, 2025

The Committee will discuss new drug application (NDA) 215244, for elamipretide hydrochloride injection, submitted by Stealth BioTherapeutics Inc., for the treatment of Barth Syndrome.

Read More October 10, 2024: Meeting of the Cardiovascular and Renal Drugs Advisory Committee – 10/10/2024
US FDA

International Foodsource, LLC. Issues Allergy Alert in Nonpareil, Semi-Sweet Chocolate (Christmas Seeds) Sold as Dark Chocolate Nonpareils
ByDossier Experts June 21, 2025

International Foodsource, LLC of Randolph NJ is recalling 10 oz packages of Southeastern Grocers Dark Chocolate Nonpareils, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume t

Read More International Foodsource, LLC. Issues Allergy Alert in Nonpareil, Semi-Sweet Chocolate (Christmas Seeds) Sold as Dark Chocolate Nonpareils
US FDA

Sabores Bakery, Dba Sabores A Tu Mesa, Issues Allergy Alert on Undeclared Milk in Mousse Desserts
ByDossier Experts June 21, 2025

Sabores Fit Bakery of Kissimmee, FL is recalling MOUSSE DESSERTS, because they may contain undeclared Milk, Eggs, Soy Ingredients (Soybean oil, Soy Lecithin), Wheat, Tree Nuts ( Almonds, Hazelnuts ). People who have an allergy or severe sensitivity to these allergens run the risk of serio

Read More Sabores Bakery, Dba Sabores A Tu Mesa, Issues Allergy Alert on Undeclared Milk in Mousse Desserts
US FDA

New England Home Therapies Inc. Southborough, MA. 483 Issued 01/27/2016
ByDossier Experts June 20, 2025

Record Date 01/27/2016
FEI Number 1000120535
Firm Name New England Home Therapies Inc.
Record Type 483
State MA
Establishment Type Producer of Sterile Drug Products

Read More New England Home Therapies Inc. Southborough, MA. 483 Issued 01/27/2016
US FDA

Essential Pharmacy Compounding, Omaha, NE., 483 Issued 05/22/2015
ByDossier Experts June 20, 2025

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 Products

Read More Essential Pharmacy Compounding, Omaha, NE., 483 Issued 05/22/2015
US FDA

Advanced Nutriceuticals LLC. Indianapolis, IN. 483 issued 11/22/2024
ByDossier Experts June 20, 2025

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/22/2024
Short Title (70 char) Advanced Nutriceuticals LLC. Indianapolis, IN. 483 issued 11/22/2024
FEI Number 3010039017
Firm Name Advanced Nutriceuticals LLC
Record Type 483
State IN
Establishment Type Steri

Read More Advanced Nutriceuticals LLC. Indianapolis, IN. 483 issued 11/22/2024
US FDA

Ideal Specialty Apothecary Inc., dba Ideal Pharmacy, Union, NJ. 483 Issued 08/31/2017
ByDossier Experts June 20, 2025

Ideal Specialty Apothecary Inc., dba Ideal Pharmacy, Union, NJ. 483 Issued 08/31/2017

Task Description Request Please post to the 2017 Pharmacy Inspections and Related Records Web page
Record Date 08/31/2017
FEI Number 3013505558
Firm Name Ideal Specialty Apothecary Inc., dba Ideal Pharmacy
Record

Read More Ideal Specialty Apothecary Inc., dba Ideal Pharmacy, Union, NJ. 483 Issued 08/31/2017
US FDA

Akorn Pharmaceuticals Inc. Decatur, IL. 483 Issued 06/10/2016
ByDossier Experts June 20, 2025

Akorn Pharmaceuticals Inc. Decatur, IL. 483 Issued 06/10/2016

Read More Akorn Pharmaceuticals Inc. Decatur, IL. 483 Issued 06/10/2016

The Knowledge Shelf

STAQ Pharma of Ohio, LLC. Columbus, OH. 483 issued 05/16/2025

Guidance: AI Airlock Background

AI breakthroughs drive expansion of ‘Airlock’ testing programme to support AI-powered healthcare innovation

Guidance: AI Airlock Phase 2 application

October 10, 2024: Meeting of the Cardiovascular and Renal Drugs Advisory Committee – 10/10/2024

International Foodsource, LLC. Issues Allergy Alert in Nonpareil, Semi-Sweet Chocolate (Christmas Seeds) Sold as Dark Chocolate Nonpareils

Sabores Bakery, Dba Sabores A Tu Mesa, Issues Allergy Alert on Undeclared Milk in Mousse Desserts

New England Home Therapies Inc. Southborough, MA. 483 Issued 01/27/2016

Essential Pharmacy Compounding, Omaha, NE., 483 Issued 05/22/2015

Advanced Nutriceuticals LLC. Indianapolis, IN. 483 issued 11/22/2024

Ideal Specialty Apothecary Inc., dba Ideal Pharmacy, Union, NJ. 483 Issued 08/31/2017

Akorn Pharmaceuticals Inc. Decatur, IL. 483 Issued 06/10/2016

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