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Johnson Memorial Cancer Center - Oct. 19, 2018

Issue Date

Oct 19, 2018

Region

Northeast

Category

Drug
$117.00

Johnson Memorial Cancer Center

Contact Name

Stuart E. Rosenberg

Contact Title

President

Form483 Address 1

142 Hazard Ave.

Form483 Address 2

Form483 City

Enfield

Form483 State

CT

Form483 Postal

06082-4520

Form483 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, John P. Mistler