OSRX, Inc. dba SMK - Sept. 23 2021
Issue Date
Sep 23, 2021
Region
Pacific
Category
Drug
$117.00
Contact Name
Amy K. Frost
Contact Title
Pharmacist-In-Charge
Address 1
1120 Kensington Ave.
Address 2
Unit E
City
Missoula
State
MT
Zip/Postal Code
59801
Country
United States
Inspection Range
Sep 15, 2021 - Sep 23, 2021
Pages
2
First Observation
Your firm's current laminar airflow studies (smoke studies) of the ISO 5 … Laminar Airflow Workstation were not performed under conditions showing aseptic operations that are representative of your current compounding practices nor did they emulate all crtical unit operations and intervenntions used during compounding of your sterile drug products.
Investigator(s): Kenneth O. Gee and Sangeeta M. Khurana