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Nesher Pharmaceuticals, LLC - July 31, 2019

Issue Date

Jul 31, 2019

Region

Southwest

Category

Drug
$117.00

Nesher Pharmaceuticals, LLC

Contact Name

Kalwinder S. Bolla

Contact Title

Senior Director of Operations

Form483 Address 1

13910 Saint Charles Rock Rd.

Form483 Address 2

Form483 City

Bridgeton

Form483 State

MO

Form483 Postal

63044-3826

Form483 Country

United States

Inspection Range

Jul 29, 2019 - Jul 31, 2019

Pages

2

First Observation

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Bei Y. He, Wayne D. McGrath