FDA 483 - Americare Compounding, LLC. - June 22, 2015

This FDA Form 483, issued to Thomas D'Angelo, Pharmacist/Co-Owner of Americare Compounding, LLC, a producer of sterile drug products located at 319 Nassau Blvd., Garden City South, New York, details observations from an inspection conducted on June 10, 11, 12, and 22, 2015.

The inspection revealed multiple deficiencies in aseptic processing and quality control. Observation 1 notes inadequate systems for maintaining aseptic conditions, specifically the lack of dynamic smoke studies in ISO 7 and ISO 5 clean rooms and clutter on the ISO 5 work table during processing. Observation 2 highlights the absence of established procedures to prevent microbiological contamination, including no media fills/process simulations and no hold time study for sterile diluents.

Observation 3 states that sterile drug lots are not tested for sterility and/or endotoxins prior to or after distribution. Observation 4 details inappropriate clothing for personnel, including exposed skin/hair, use of non-sterile personal items (eyeglasses, goggles, hair net, booties, undergarments worn outdoors), and re-use of gowns.

Observation 5 identifies deficiencies in environmental monitoring, such as no dynamic non-viable particulate monitoring in ISO 5 zones, no continuous air pressure differential monitoring, media plates lacking disinfectant neutralizers, and infrequent viable air counts and surface/glove tip microbial testing. Observation 6 points out inadequate cleaning and disinfection,