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Amneal Pharmaceuticals Pvt Ltd. - April 5, 2019

Issue Date

Apr 05, 2019

Region

HQ

Category

Drug
$117.00

Amneal Pharmaceuticals Pvt Ltd.

Contact Name

Sanjay Kumar Jain

Contact Title

President

Form483 Address 1

Sarkhej - Bavla Highway

Form483 Address 2

Form483 City

Matoda, Gujarat

Form483 State

Form483 Postal

382213

Form483 Country

India

Inspection Range

Mar 27, 2019 - Apr 05, 2019

Pages

1

First Observation

Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
Investigator(s): Matthew Casale