Gland Chemical Private Limited

FDA 483 - Gland Chemical Private Limited

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Record Details

Pfizer Healthcare India Private Limited in Waluj, India, was inspected and cited for multiple deficiencies related to quality unit oversight, material control, stability data, production records, equipment qualification, and laboratory controls. The observations indicate a lack of robust quality systems, potentially impacting the quality and purity of active pharmaceutical ingredients. This suggests significant concerns regarding the firm's adherence to good manufacturing practices.

Company: Gland Chemical Private Limited
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Anastasia M. Shields (Consumer Safety Officer )
Linda F. Murphy (SVP Consulting & Operations)

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