Apotex Research Private LimitedMarch 15, 2024

FDA 483 - Apotex Research Private Limited - March 15, 2024

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Record Details

Apotex Research Private Limited in Bangalore, India, received a Form 483 during an FDA inspection from March 11-15, 2024. The firm was cited for failing to adequately investigate unexplained discrepancies and anomalous results, and for not establishing written procedures for production and process controls. Additionally, the quality control unit's responsibilities and procedures were not fully followed, indicating significant deficiencies in their quality system.

Company: Apotex Research Private Limited
Inspection Date: March 15, 2024
Product Type: Drugs
Office: Office of Partnerships
People: Jeffrey P. Raimondi (Consumer Safety Officer)
Aditi Thakur

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