# FDA 483 - ABRYL LABORATORIES PRIVATE LIMITED - January 22, 2022

Source: https://www.globalkeysolutions.net/records/483/abryl-laboratories-private-limited/97c07104-f34e-415b-b393-25fe9f8813bb

> FDA 483 for ABRYL LABORATORIES PRIVATE LIMITED on January 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ABRYL LABORATORIES PRIVATE LIMITED
- Inspection Date: 2022-01-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Abryl Laboratories Private Limited in Derabassi, Punjab, India, a sterile manufacturer, revealed significant deficiencies across multiple areas. The firm failed to adequately validate aseptic and sterilization processes, maintain proper environmental controls, and ensure robust laboratory and quality control systems. These issues collectively indicate a lack of sterility assurance for their drug products.

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## Related Officers

- [Rita Kabaso](https://www.globalkeysolutions.net/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1