Baxter is permanently removing all Life2000 Ventilation Systems after discovering a cybersecurity issue that may allow unauthorized access to the device
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Study Data Technical Conformance Guide – Technical Specifications Document
This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.GenoGenix, LLC. Boca Raton, FL. 483 issued 07/18/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/18/2025
Short Title (70 char) GenoGenix, LLC. Boca Raton, FL. 483 issued 07/18/2025
FEI Number 3032144832
Firm Name GenoGenix, LLC
Record Type 483
State FL
Establishment Type Outsourcing FacilityRight Value Drug Stores, LLC. Irving, TX. 483 issued 07/18/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/18/2025
Short Title (70 char) Right Value Drug Stores, LLC. Irving, TX. 483 issued 07/18/2025
FEI Number 3010589333
Firm Name Right Value Drug Stores, LLC
Record Type 483
State TX
Establishment Type OutsourciMedical Gases — Current Good Manufacturing Practice
Pharmaceutical Quality/Manufacturing Standards (CGMP)So Delicious Dairy Free® Salted Caramel Cluster Frozen Dessert Pints Voluntarily Recalled by Danone U.S. Due to Potential Presence of Foreign Material
WHITE PLAINS, N.Y. and LOUISVILLE, Colo., December 15, 2025 – Danone U.S. is voluntarily recalling its So Delicious Dairy Free® Salted Caramel Cluster Non-Dairy Frozen Dessert pints with multiple best-by expiration dates before 08 Aug 2027 at retail stores nationwide due to the potential presence ofWells Pharmacy Inc. Dyersburg, TN. 483 issued 04/25/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 04/25/2025
Short Title (70 char) Wells Pharmacy Inc. Dyersburg, TN. 483 issued 04/25/2025
FEI Number 3011761321
Firm Name Wells Pharmacy Inc.
Record Type 483
State TN
Establishment Type Outsourcing Facility