FDA 483 - Chastains Inc. dba Owl Tri State Pharmacy - August 27, 2021

An FDA inspection of Chastains Inc. dba Owl Tri State Pharmacy, a producer of non-sterile drug products located at 1275 Highland Ave, Clarkston, WA, was conducted from August 23-27, 2021. The inspection, led by Investigator Roger F Zabinski, identified one observation related to non-microbial contamination in the production area.

Specifically, the observation noted: a. Glassware, including beakers and mortars, stored as clean on shelves, were found to be dirty, greasy, or with corrosion stains. This dirty glassware was reportedly used for both non-hazardous and USP-800 hazardous drug production. b. Large pieces of dust were observed hanging from an air vent and ceiling grids above the entrances to both the USP-800 lab and the non-hazard lab, as well as above a dispenser machine. The top of the dispenser machine itself was covered with copious amounts of dust. c. Sinks in the pharmacy area and in each production lab exhibited corrosion stains. Additionally, the linoleum floor around the sink in the non-hazard lab was heavily soiled and had unsealed open gaps where it met the wall.

This document serves as inspectional observations and does not represent a final Agency determination of compliance.