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Mayne Pharma, Inc. - July 12, 2019

Issue Date

Jul 12, 2019

Region

Southeast

Category

Drug
$117.00

Mayne Pharma, Inc.

Contact Name

Troy T. Woelfel

Contact Title

Vice President and General Manager

Form483 Address 1

1240 Sugg Pkwy.

Form483 Address 2

Form483 City

Greenville

Form483 State

NC

Form483 Postal

27834-9006

Form483 Country

United States

Inspection Range

Jul 08, 2019 - Jul 12, 2019

Pages

2

First Observation

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Investigator(s): Lakeesha M. Foster, Claire M. Minden