# FDA 483 - ABRYL LABORATORIES PRIVATE LIMITED - November 20, 2023

Source: https://www.globalkeysolutions.net/records/483/abryl-laboratories-private-limited/6e5d4f05-3a61-4d41-ad96-385876ff37da

> FDA 483 for ABRYL LABORATORIES PRIVATE LIMITED on November 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ABRYL LABORATORIES PRIVATE LIMITED
- Inspection Date: 2023-11-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Abryl Laboratories Private Limited, a sterile drug manufacturer in Derabassi, Punjab, India, revealed significant deficiencies across multiple areas. The firm was cited for inadequate laboratory records, failure to thoroughly investigate discrepancies and out-of-specification results, and a lack of written and followed quality control unit procedures. Additionally, the inspection found issues with manufacturing process controls, including cleaning and process validation, and insufficient employee training for critical operations.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

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