ABRYL LABORATORIES PRIVATE LIMITEDSeptember 26, 2025

FDA 483 - ABRYL LABORATORIES PRIVATE LIMITED - September 26, 2025

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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)

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