FDA 483 - MOORE'S COMPOUNDING PHARMACY - January 13, 2017

On January 13, 2017, the FDA issued a Form 483 to Moore's Compounding Pharmacy in Corpus Christi, TX, following an inspection from January 4-13, 2017. The facility is a producer of non-sterile drugs, and the report was issued to Mr. Kelby D. Gorman, Pharmacist In Charge.

The sole observation noted was a failure to follow procedures designed to prevent objectionable microorganisms in non-sterile drug products. Specifically, the firm's SOP 7.090, Version 1.0, "REQUIRED GARB FOR NON-STERILE COMPOUNDING AREA," effective November 1, 2014, mandates wearing sterile gloves or disinfecting non-sterile gloves with a sterile disinfectant.

However, on January 4, 2017, an FDA investigator observed a Certified Pharmacy Technician (CPT) handling ingredients for Tri-Est Progesterone capsules (Lot# 2017-01-03:63@16) with bare hands in the compounding hood. The CPT, who began compounding capsules around May 2015, stated they were trained to handle ingredients with bare hands before putting on non-sterile gloves. From October 1 to December 31, 2016, the firm prepared approximately [redacted] compounded capsule prescriptions. This indicates a systemic issue with adherence to established microbial