US Food and Drug Administration. guidance for industry: Q10 quality systems qpproach to pharmaceutical cGMP regulations (FDA, Rockville, MD, September 2006).

Aside from the key points outlined in the warning letter, the FDA claimed that Nuowei “does not operate an effective quality system” and called on the company’s management to “immediately ...

FDA and DOJ also took action based on longstanding ... Maintaining a culture of compliance and a mature quality system is the best way to detect and mitigate medical product and food safety ...

Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, including a unique device RefluxStop ...

20% of bioreactor runs at the Genzyme facility failed due to contamination or quality issues over 2.5 years. FDA identified 84 overdue deviation investigations, some exceeding 180 days ...

The US Food and Drug Administration (FDA) has granted 510 (k) clearance to GE HealthCare’s enhanced Voluson Expert Series ultrasound systems, which include the Voluson Expert 22, 20, and 18 models.

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a U.S. drug ingredients plant tied to its longstanding subsidiary Genzyme.