FDA 483 - SaveWay Compounding Pharmacy, Inc. - June 29, 2017

This FDA Form 483 document details observations made during an inspection of SaveWay Compounding Pharmacy, Inc., located at 31 Albe Drive Suite 1, Newark, DE 19702-1360. The inspection, conducted by Investigator Anita R Michael, took place from June 13, 2017, to June 29, 2017. The firm is identified as a producer of sterile and non-sterile drug products. The inspection was issued to Pradeep Chilakapati, Staff Pharmacist.

The sole observation noted is a deficiency in aseptic processing areas regarding the system for monitoring environmental conditions. Specifically, pressure differentials between the ISO 7 room and ISO 8 room, which have different air classifications, were not monitored prior to or during sterile drug production. This is explicitly noted as a repeat observation, indicating a previously identified and uncorrected issue. The FEI Number for the facility is 3006101483.