Spoonamore Drug Co Inc – FDA EIR, Mar 14, 2017

An FDA inspection of Spoonamore Drug Co Inc, a 503A compounding pharmacy in Louisville, KY, was conducted from January 17 to March 14, 2017. This inspection, carried out under FDA guidelines for sterile drug and drug manufacturing processes, followed a previous inspection in 2015 that resulted in an FDA-483 and a Warning Letter. The current inspection identified several significant issues. Three objectionable conditions were cited on an FDA-483 form, including the firm producing intrathecal products from non-sterile ingredients without endotoxin control or final product testing, inadequate smoke studies for ISO 5 hoods failing to demonstrate dynamic airflow, and the use of non-sterile wipes in sterile compounding areas. Additionally, eight verbal discussion items were raised. Notably, the firm had not fully corrected two issues from the 2015 inspection: personnel in sterile areas wore inappropriate, non-sterile clothing, and antimicrobial effectiveness testing was not performed for sterile multi-dose products like Tri-Mix and Bi-Mix. Other concerns included the lack of complaint handling procedures, absence of equipment calibration protocols, and failures in documenting cleaning and filter maintenance for non-sterile compounding areas. Management committed to providing a written response to these findings within 15 business days.