For the second time in about six weeks, India’s Dr. Reddy’s has been rebuffed by the FDA for its efforts to deal with the problems the agency had outlined in a warning letter two years ago. In a ...

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 ...

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 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 ...

FDA inspections ensure compliance with GMPs, focusing on documentation practices, SOPs, and non-conformances. Inspections can be surveillance, for-cause, application-based, or follow-up, and occur ...

Another day brings more bad news for still-closed SanGar Fresh Cut Produce. This time it was the release of the FDA Form 483 report containing observations of the federal food safety inspectors who ...

When was your last FDA inspection? You may believe that the likelihood of an FDA inspection happening to your company is low. However, medical device companies registered with FDA with class II and ...