The FDA handed a Form 483 to RC Outsourcing after finding it does not test each batch of injectable product for endotoxin.
The Lowellville, Ohio-based company failed to show that it had investigated instances when environmental and personnel microbial counts exceeded alert levels, according to the Feb. 9 document. Further, a door leading from one room into the anteroom — as well as the door leading from the anteroom into the clean room — had gaps at the bottom of about one inch.
RC did not monitor differential pressure readings frequently during aseptic production, according to the form. It did not record differential pressure values or thoroughly review unexplained discrepancies, whether or not the batch was distributed.