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Company: Pharmaceutical Innovations
Plant: Newark, NJ
Warning letter: July 29, 2011

The small New Jersey company Pharmaceutical Innovations can serve as warning to other drugmakers of what can happen if the FDA decides they are not taking seriously enough the observations from inspections. In April, U.S. marshals descended on the company and seized all lots of Other-Sonic Generic Ultrasound Transmission Gel manufactured that the agency believed to contain dangerous levels of bacteria tied to 16 infections at a neonatal intensive care unit at a Michigan hospital that used the product.

The FDA in July 2011 raised concerns over cleanliness and sterilization during its inspection. In its warning letter, the FDA said the company did not test product adequately to ensure that it was sterile and did not make sure equipment used to sterilize the product was properly maintained and calibrated.

It also noted that the company did not thoroughly investigate a complaint that babies in a NICU were infected by pseudomonas. "The hospital's investigation led to culturing your ultrasound 8 oz bottles and 5 liter gel which tested positive for the pseudomonas organism." The company told the FDA that the hospital had not properly used the product but the FDA said the company had failed to establish a procedure to make sure that same thing didn't happen again. In follow-up tests of both opened and unopened containers of the gel, the hospital found bacteria in both, and further testing in February again found contamination.

That was followed by the filing of papers in federal court and the arrival at the plant of U.S. marshals bearing guns and badges and the authority to confiscate product.