A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. | The FDA ...

Their findings amounted to the FDA issuing the McDonald's supplier a so-called Form 483, a list of citations over conditions inspectors worried could be "injurious to health." That facility had ...

"At the end of the inspection, a 'Form 483' has been issued with 9 observations. With respect to the mentioned inspection, we have received a letter from USFDA classifying the inspection as ...

A recent webinar in the HDA’s Traceability Webinar series looked at the common question, ‘what if my supplier isn’t compliant ...

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.

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 ...

Lupin has announced that the the United States Food and Drug Administration (US FDA) has concluded the pre-approval inspection of the company's Edaravone Oral Suspension, located at its manufacturing ...

US FDA completes pre-approval inspection of Lupin’s edaravone oral suspension facility in Somerset with no observations: Our Bureau, Mumbai Monday, February 3, 2025, 14:45 Hrs [ ...

The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...

Mumbai: Global pharma major Lupin Limited has announced that the United States Food and Drug Administration (U.S. FDA) has ...