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483
•ABRYL LABORATORIES PRIVATE LIMITED•September 26, 2025

ABRYL LABORATORIES PRIVATE LIMITED – FDA 483, Sep 26, 2025

Record Details

Abryl Laboratories Private Limited, a sterile drug manufacturer in District S.A.S. Nagar (Mohali), India, was cited for significant deficiencies across its aseptic and sterilization processes. The inspection revealed inadequate validation of critical manufacturing steps, poor environmental monitoring, and insufficient laboratory controls. Repeat observations highlighted persistent issues with discrepancy investigations and computer system controls, indicating systemic quality control failures.

Company
ABRYL LABORATORIES PRIVATE LIMITED
Inspection date
September 26, 2025
Product type
drugs
Office
Foreign - CDER (Non-Bioresearch Monitoring)
People
  • Hung H. Do
  • Chad W. Rice (investigator)
  • Sandra A. Boyd (Drug National Expert)
View Company Profile

ID · de803bfe-4f89-45c2-a530-9fd457dd5870

Other documents for ABRYL LABORATORIES PRIVATE LIMITED
  • 483 - 2024-08-20August 20, 2024
  • 483 - 2023-11-20November 20, 2023
  • EIR - 2022-12-06December 6, 2022
  • 483 - 2022-12-06December 6, 2022
  • 483 - 2022-01-22January 22, 2022

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