News

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian firm that utilizes Contract Manufacturing Organizations (CMOs) to manufacture nasal spray products. The FDA criticises the lack of a quality unit (QU), an insufficient investigation into microbial contamination and an inadequate stability program.

In March 2022, the U.S. Food and Drug Administration (FDA) sent a Form 483 to Cadila Healthcare’s sterile injectable manufacturing site in Jarod, India. Among other observations, it came out that the stability program is not followed to complete the testing within the predefined time frame. Some tests were even delayed by more than 120 days.

In March 2022, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to an American over-the-counter (OTC) drug product manufacturer due to significant violations of Current Good Manufacturing Practice (CGMP). The violations were related to identity testing, training, calibration, qualification and quality unit oversight.

Both the "IRIS guide to registration and RPIs" and the "IRIS guide for applicants" were updated in February and published on the EMA website.