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

Source: https://www.keypedia.com/records/483/abryl-laboratories-private-limited/de803bfe-4f89-45c2-a530-9fd457dd5870

> FDA 483 for ABRYL LABORATORIES PRIVATE LIMITED on September 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ABRYL LABORATORIES PRIVATE LIMITED
- Inspection Date: 2025-09-26
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

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## Related Officers

- [Hung H. Do](https://www.keypedia.com/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)
- [investigator](https://www.keypedia.com/people/chad-w-rice/b00f381a-744d-4e5e-90bf-07f60f494afc)
- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

Company: https://www.keypedia.com/companies/abryl-laboratories-private-limited/2c82dd5b-3db2-4630-9c9c-45113aa3d31f

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8