JD Supra

Form FDA 483 Response Best Practices Announced by the FDA

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency ...
FiercePharma

Serial FDA offender Lupin lands 17-observation write-up at Indian biotech plant

Despite repeated manufacturing infractions this year, Lupin has found itself on the receiving end of yet another FDA rebuke. Following an October FDA inspection, Lupin’s biotech manufacturing facility ...
WGN Radio

SGS's Shanghai Health Science Laboratory Completes US FDA Inspection with Zero 483 Observations

For a third consecutive time, the facility was not issued a Form FDA 483 at the conclusion of the US FDA’s comprehensive inspection (Zero 483 inspectional observations), becoming the first third-party ...
Business Insider

NeXtGen Biologics Successfully Completes First FDA Audit with Zero 483 Observations

GAINESVILLE, Fla., Oct. 28, 2025 (GLOBE NEWSWIRE) -- NeXtGen Biologics announced today the successful completion of a two-day inspection by the U.S. Food and Drug Administration (FDA). The inspection ...
FiercePharma

Under FDA scrutiny, Aurobindo's Eugia tallies a 5th Form 483 in less than a year

Eugia remains under FDA scrutiny as the unit of Indian drugmaker Aurobindo has received its fifth Form 483 since December. The company’s latest slap from the U.S. regulator stems from an April 25 to ...
Reuters

Alkem Laboratories Gets Form 483 With 13 Observations After U.S. FDA Inspection At Co's Amaliya Facility

* SHALL PUT TOGETHER DETAILED RESPONSE WITH ADEQUATE CORRECTIVE AND PREVENTIVE MEASURES TO ADDRESS US FDA OBSERVATIONS * ‍IN RESPONSE TO FORM 483 BY FDA AT CO'S ST LOUIS FACILITY, CO HAS SUBMITTED ...