FDA spars with Texas company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco, Texas, company that its human amniotic products are “unlicensed” and “unapproved,” and ...
Food Safety News3d
FDA warns seafood companies over HACCP violations and potentially adulterated products
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
JD Supra21d
Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration ...
Acsh.org9d
FDA Warning Letter
The crisis is long over, but if you were a young family with babies three years ago, scary memories of escalating health worries and retail stores bereft of infant formulas remain.
Becker's Hospital Review15d
FDA warns Sanofi over manufacturing violations
The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan. 15, ...
Food Safety News10d
FDA warns bakery for food safety violations, including sanitation and allergen control failures
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its ...
Medical Xpress13d
FDA warns Sanofi of manufacturing irregularities at key facility
On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA inspectors found irregularities with the facility's ...
Becker's Hospital Review7d
FDA warns GLP-1 compounder over safety rules
The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, ...
Applied Therapeutics, Inc. Sued for Securities Law Violations - Investors Should Contact Levi & Korsinsky for More Information – APLT
NEW YORK, NY / ACCESS Newswire / February 5, 2025 / If you suffered a loss on your Applied Therapeutics, Inc. (NASDAQ:APLT) investment and want ...
Amid recalls, Minnesota medtech exec says she was pressured to disregard safety law
Susan Krause of Rosemount alleges New Jersey-based Integra LifeSciences pressured her to lie to regulators. Integra says ...