Hawaii Health Systems Corp. dba Kona Community Hospital Pharmacy - Dec. 13, 2019
Issue Date
Dec 13, 2019
Region
Pacific
Category
Drug
$117.00
Contact Name
Tawnie L. McDonald
Contact Title
Quality Director
Address 1
79-1019 Haukapila St.
City
Kealakekua
State
HI
Zip/Postal Code
96750
Country
United States
Inspection Range
Dec 02, 2019 - Dec 13, 2019
Pages
7
First Observation
You did not make adequate product evaluation and take remedial action where actionable microbial
contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic
production.
Investigator(s): Marcus F. Yambot