Sterility Remains a Concern for Manufacturer of Seized Gel

Newark, N.J.-based Pharmaceutical Innovations failed to resolve contamination concerns several months after contaminated ultrasound gel was confiscated by law enforcement in April 2012, a 20-count Form 483 shows. U.S. marshals seized all lots of the company’s ultrasound gel manufactured between June and December 2011, after an FDA analysis found dangerous bacteria in product samples.
The GMP Letter