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

This FDA Form 483 was issued to Moore's Compounding Pharmacy in Corpus Christi, TX, a producer of non-sterile drugs, on January 13, 2017, following an inspection from January 4-13, 2017. 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, effective 11-01-14, titled "REQUIRED GARB FOR NON-STERILE COMPOUNDING AREA," mandates that when non-sterile gloves are used, they must be disinfected with sterile (b)(4) or an appropriate disinfectant.

On January 4, 2017, an FDA investigator observed a Certified Pharmacy Technician (CPT) handling ingredients for Tri-Est Progesterone (b)(4)/200mg SR capsules (Lot# 2017-01-03:63@16) with bare hands in the (b)(4) hood before putting on non-sterile gloves. The CPT, who began compounding capsules in May 2015, stated they were trained to handle ingredients with bare hands initially. From October 1, 2016, to December 31