Valary Lab Private LimitedAugust 22, 2022

FDA 483 - Valary Lab Private Limited - August 22, 2022

Record Details

Valary Lab Pvt Ltd, an API manufacturer, received a Form 483 citing two observations related to manufacturing controls. The firm failed to document deviations and conduct appropriate investigations in manufacturing batch records. Additionally, manufacturing batch and control records were found to contain incomplete information regarding production and testing.

Company: Valary Lab Private Limited
Inspection Date: August 22, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Alan P. Kurtzberg (Consumer Safety Officer (Drug Specialist))

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ID · 8b127dff-e46d-4e39-a530-751dfdce5182