In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring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 ...
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 ...
UCB Farchim, a unit of Belgian drugmaker UCB, has been hit with a Form 483 from the FDA, with the observations mainly centered around quality control and record-keeping. The four-observation ...
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 ...
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 ...
* 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 ...
Torrent Pharmaceuticals Limited has informed that the United States Food and Drug Administration (USFDA) has completed an ...
Having noticed an uptick in medical device recalls and FDA warning letters to medtech companies this year, it seems an appropriate time to look back on a Form 483 from December 2016 that surprised ...
The U.S. Food and Drug Administration is scoffing at a "Doe" lawsuit filed by a company attorney trying to prevent being identified in an agency inspection report on the grounds disclosure would cause ...
The MarketWatch News Department was not involved in the creation of this content. GAINESVILLE, Fla., Oct. 28, 2025 (GLOBE NEWSWIRE) -- NeXtGen Biologics announced today the successful completion of a ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results