In a recently published report from the Office of the Inspector General (OIG), in the last 2 years, FDA has increased GMP inspections of generic drug manufactures by almost two-thirds. About 90% of these inspections were surveillance inspections in which FDA randomly inspected facilities for compliance with GMP. FDA focused its inspections on “high risk” sites and … Read more
FDA issued a proposed rule of 1 May 2015 to revise a previous law from 20 years ago regulating over-the-counter (OTC) antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital. Hand cleaners are generally recognized as safe and effective, however recent scientific data has cast … Read more
Food facilities are not expected to report to FDA incidences of contamination unless they suspect that the contaminated food has entered distribution. Hence most food contamination found during manufacture are not reported to the FDA. Recent outbreak of listeria contamination at Blue Bells plants exposed this gap between expectation from and the reality of enforcement … Read more
