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Home » Form 483 » Petra Hygienic Systems Int., Ltd.

Petra Hygienic Systems Int., Ltd. - Dec. 21, 2018

Issue Date

Dec 21, 2018

Region

HQ

Category

Drug
$117.00

Contact Name

Salvatore Maduri

Contact Title

President

Address 1

86 Moyal Ct.

City

Concord

State

Ontario

Zip/Postal Code

L4K 4R8

Country

Canada

Inspection Range

Dec 17, 2018 - Dec 21, 2018

Pages

4

First Observation

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
Investigator(s): William J. Leonard
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