Unapproved New Drugs/Misbranded
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US Specialty Formulations LLC. Allentown, PA. 483 issued 1/14/2026
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 1/14/2026
Short Title (70 char) US Specialty Formulations LLC. Allentown, PA. 483 issued 1/14/2026
FEI Number 3010680515
Firm Name US Specialty Formulations LLC
Record Type 483
State PA
Establishment Type OutsouNon-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension.Compounding Quality Center of Excellence | Engage with the Compounding Quality Center of Excellence
Engage with the Compounding Quality Center of ExcellenceBiopreventative Company LLC dba Biopreventative – 09/09/2025
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internetwww.24hreup.biz – 700358 – 04/23/2025
Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the InternetNews from Emerging Technology Program (ETP)
CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.