FDA 483 - Infusion Options, Inc. - June 01, 2017

This FDA Form 483 document details observations from an inspection of an outsourcing facility. The facility's procedures for preventing microbiological contamination of sterile drug products lack validation of the sterilization process, specifically, media fills are not representative of routine production volumes and do not incorporate worst-case conditions.

Personnel gowning practices were found to be deficient during aseptic operations, with one pharmacist's sterile glove cuff below the gown sleeve exposing the wrist, and another's mask repeatedly sliding down their nose without re-gowning.

Environmental monitoring in aseptic processing areas was inadequate; active viable air sampling was conducted after operations and without personnel present, contrary to the firm's own procedures. The incubator for TSA plates was not consistently monitored for temperature, and plates were incubated at only one temperature, limiting growth recovery.

Drug product testing and release procedures are deficient. Compounded batches of drug products are not tested for potency or endotoxin, despite purporting to be pyrogen-free.

Finally, the labels of the outsourcing facility's drug products are deficient, lacking a list of active and inactive ingredients, identified by established name and quantity or proportion, as required by section 503B(a)(10)(A) and (B). Examples of non-compliant labels include various injectable bags and syringes containing drugs like Oxytocin, Cefazolin, Penicillin G Potassium, Bivalirudin, Ceftriaxone, Ampicillin-Sulbactam, and Piperacillin