Johnson Memorial Cancer Center - Oct. 19, 2018
Issue Date
Oct 19, 2018
Region
Northeast
Category
Drug
$117.00
Contact Name
Stuart E. Rosenberg
Contact Title
President
Address 1
142 Hazard Ave.
City
Enfield
State
CT
Zip/Postal Code
06082-4520
Country
United States
Inspection Range
Oct 01, 2018 - Oct 19, 2018
Pages
8
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): Erik W. Koester and John P. Mistler