FDA 483 - VP Pharmacy Partners LLC - February 03, 2015

An FDA inspection of Spoonamore Drug Co Inc, a sterile drug producer located at 4014 Dutchmans Lane, Louisville, KY, was conducted from January 13, 2015, to February 3, 2015. The inspection revealed seven observations.

Observation 1 noted deficiencies in environmental monitoring within aseptic processing areas. Specifically, there were no records for pressure differential limits between ISO 5 laminar flow hoods and the ISO 7 Buffer/IV Prep Room, or between the Buffer/IV Prep Room and the ISO 8 Anteroom. Pressure gauges were absent for monitoring air pressure between ISO 7 and ISO 8 areas, and no environmental monitoring samples were taken from the curtain door between the ISO 7 I.V. Prep Room and the ISO 8 anteroom.

Observation 2 indicated that an adequate number of batches of each drug product were not tested to determine appropriate expiration dates. This included a lack of stability test data for Tri-Mix injections (30-2-20, 30-1-20, 15-1-10) with a 120-day beyond use date, Bi-Mix 30-1 injection with a 180-day beyond use date, and Vancomycin and Tobramycin beads with a 180-day beyond use date.

Observation 3 stated that each batch of drug product purporting to be sterile