Morton Grove, IL, January 21, 2014 – Regis Technologies, Inc., today reported that it successfully passed a recent U.S. Food & Drug Administration (FDA) audit with no Form 483 observations. Form 483 ...

Alvotech (NASDAQ:ALVO) is one of the most promising penny stocks according to Wall Street analysts. On May 11, Alvotech ...

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 ...

The US Food and Drug Administration (FDA) has released the text of a Form 483 sent to biopharmaceutical manufacturer Biogen Idec, outlining a series of alleged deficiencies affecting the manufacture ...

Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an ...

An FDA inspection of a Biocon API plant in Bangalore that concluded last month found a number of issues, including with the plant’s quality-assurance department. But the Indian drugmaker shrugged it ...

In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers should approach Form 483 responses to ...

As a medical device company, you do know that an FDA inspection will happen, right? FDA is supposed to inspect all medical device companies with class II (and higher) devices at least every two years.

The Food and Drug Administration (FDA) is the federal agency charged with ensuring the safety of foods, medications and other consumer products sold in the United States. In carrying out its duties, ...

Following inspections in late September, India-based generic drugmakers Lupin, Aurobindo and Cipla received Form 483s posted last week by the US Food and Drug Administration (FDA) for observations ...