JD Supra

FDA Issues First-of-Its Kind Guidance on Expectations for Drug Manufacturing 483 Responses

Compliance & Enforcement Team explores the U.S. Food and Drug Administration’s new draft guidance on responding to FDA Form 483 ...
JD Supra

FDA Issues Draft Guidance for Responses to Form 483 Drug CGMP Inspections

On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of ...
FiercePharma

Rentschler slapped with FDA Form 483 citing lax manufacturing procedures

Rentschler Biopharma, a German CDMO, was cited by the FDA with a Form 483 following an inspection that revealed nine observations focused on procedural gaps and records keeping. FDA inspectors visited ...
FiercePharma

FDA hits Spanish drug substance maker Bioiberica with a Form 483

The FDA is citing Spanish drug materials maker Bioiberica for a number of manufacturing issues, which are outlined in a Form 483. The facility, which is located in Palafalls, Spain, was inspected by ...
Becker's ASC

FDA Form 483 Outlines Conditions Observed at NECC

The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...
MD&M East

Responding to FDA Form 483 and Warning Letters: Dos and Don’ts

There is a scene in the old Rodney Dangerfield movie Back to School in which Dangerfield’s character, Thornton Melon, is preparing to take an oral exam from all his professors. One particularly stern ...
CNBCTV18

Lupin receives form 483 with 2 observations after US FDA inspection at Ankleshwar facility

The US FDA has completed an inspection of Lupin’s Ankleshwar manufacturing facility conducted from March 2 to March 7, 2026, and issued a Form 483 with two observations. The company said it will ...
MD&M East

That Time FDA was ‘Unusually Thorough’ on a Form 483

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 ...
MarketWatch

2 Day Virtual Drug and Biotech Products FDA Regulatory Compliance Training Course: Practical Applications of the Graded Approach in Manufacturing, Testing, and Quality Control ...

The "FDA Regulatory Compliance for Drug and Biotech Products (Nov 12th - Nov 13th, 2025)" training has been added to ResearchAndMarkets.com's offering. Regulatory Compliance is the level of activity ...