2024 First Generic Drug Approvals

In May 2025, Medtronic issued a voluntary recall notification to global customers related to specific Newport™ HT70 and HT70 Plus ventilators and certain related Newport™ service parts. The FDA recently designated this voluntary action by Medtronic as a Class I recall.
With this recall, Medtronic i

Affected device lots may experience tip separation; field complaints reported that the tip separation can occur both prior to and during patient contact.

CGMP/Finished Pharmaceuticals/Adulterated

Abbreviated New Drug Applications and following the path to generic drug approval. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 10/14/2025
Short Title (70 char) Wells Pharmacy LLC. Dyersburg, TN. Untitled Letter issued 10/14/2025
FEI Number 3011761321
Firm Name Wells Pharmacy LLC
Record Type Untitled Letter
State TN
Establishment Type Ou