FDA 483 - New Vitalis Pharmacy LLC - August 27, 2021

An FDA Form 483 was issued following an inspection on August 24, 2021, identifying multiple deficiencies in a facility producing sterile injectable drugs, specifically Testosterone Cypionate 180mg/Testosterone Propionate 20 mg/ml in 1 ml vials, lot 08242021@901.

Key observations include: * **Vermin and Non-Microbial Contamination:** Two dead flies were found in the ISO 7 cleanroom, one behind the ISO 5 hood and one near a trash can. Black debris was observed on the floor, peeling and bubbling tape with black residue was on the floor, and black residue was built up around HEPA filters on the ceiling. * **Aseptic Technique Deficiencies:** Personnel were observed hand-stoppering vials in the ISO 5 hood with their hand and forearm over exposed sterile product after filling, blocking first-pass air. * **Facility Design and Maintenance Issues:** HEPA filters in the ISO 7 cleanroom were not properly sealed, with one corner hanging loose. The ceiling caulk was jagged and rough, posing a risk of falling debris. A sprinkler head was located directly above the ISO 5 hood. * **Personnel Practices:** Gloves were not disinfected upon re-entry into the ISO 5 hood or when transferring from a lesser to higher air quality area. A bag of stoppers was