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Lupin Ltd. - Dec. 4, 2018

Issue Date

Dec 04, 2018

Region

HQ

Category

Drug
$117.00

Lupin Ltd.

Contact Name

Krishan C. Sharma

Contact Title

Site Head and Senior Vice President -Manufacturing

Form483 Address 1

Unit II, 198 - 202 New Industrial Area No. 2

Form483 Address 2

Mandideep

Form483 City

Form483 State

Madhya Pradesh

Form483 Postal

462046

Form483 Country

India

Inspection Range

Nov 26, 2018 - Dec 04, 2018

Pages

5

First Observation

Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the Active Pharmaceutical Ingredients (APIs).
Investigator(s): Christopher S. Keating, Ipesh Sha, Pratik S. Upadhyay