TEVA Pharmaceuticals USA, Inc. – FDA 483, Jul 20, 2026

TEVA Pharmaceuticals USA, Inc. in Fairfield, NJ, received a Form 483 for failing to adequately test in-process materials for strength, quality, and purity after long storage periods. The inspection revealed significant deficiencies in bulk hold time studies, which did not include assessments for finished product stability, blend uniformity, or worst-case storage conditions. These findings indicate a critical lapse in the firm's quality control processes for drug product manufacturing.