# FDA 483 - ABRYL LABORATORIES PRIVATE LIMITED - August 20, 2024

Source: https://www.keypedia.com/records/483/abryl-laboratories-private-limited/4d31e593-ab87-4745-9424-c46d5017d2e6

> FDA 483 for ABRYL LABORATORIES PRIVATE LIMITED on August 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ABRYL LABORATORIES PRIVATE LIMITED
- Inspection Date: 2024-08-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Abryl Laboratories Private Limited, a sterile drug manufacturer in Dera Bassi, India, was cited for significant deficiencies in its quality control and manufacturing processes. Observations included a lack of scientifically sound sampling plans and test procedures, failure to thoroughly investigate non-viable particle excursions, and inadequate qualification of visual inspectors for drug product inspection. These issues indicate a lack of robust controls to ensure drug product quality and purity.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)
- [Crystal Monroy](https://www.keypedia.com/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)

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

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