The FDA inspection found a lack of assurance of sterility and identified GMP violations that could impact product quality and sterility. As a result, the affected product is being recalled.
Actualités réglementaires24 août 2026•1 min de lecture
FDA Identifies GMP Violations Affecting Sterility Assurance
An FDA inspection uncovered GMP violations that may compromise product sterility and quality, prompting a recall.
Compilé par l'équipe PharmaCountry · Source : FDA.gov
Évaluations
(0)
(0)
(0)
(0)
(0)
Plus d'articles
Voir tous les articlesRecherches & Rapports
Global Finished Dosage Manufacturing Landscape 2026
5 oct. 2026
Actualités réglementairesKorea Korus hit with 1‑month manufacturing suspension over missing post‑marketing safety test
28 sept. 2026
AnalysePharma distributors set delivery cut‑offs ahead of Chuseok holiday (Sep 21‑23)
28 sept. 2026
Laissez votre note