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Synthetopes, Inc. - May 16, 2019

Issue Date

May 16, 2019

Region

Southeast

Category

Drug
$117.00

Synthetopes, Inc.

Contact Name

Yan Rotenstein

Contact Title

Pharmacist in Charge & Partial Owner

Form483 Address 1

216 Earnhardt St.

Form483 Address 2

Form483 City

Conway

Form483 State

SC

Form483 Postal

29526-8287

Form483 Country

United States

Inspection Range

May 06, 2019 - May 16, 2019

Pages

7

First Observation

Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
Investigator(s): Jessica Pressley