# FDA 483 - ABRYL LABORATORIES PRIVATE LIMITED - December 06, 2022

Source: https://www.globalkeysolutions.net/records/483/abryl-laboratories-private-limited/abbe70ac-4c8e-417a-87cc-ac9e994efc16

> FDA 483 for ABRYL LABORATORIES PRIVATE LIMITED on December 06, 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: 2022-12-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Abryl Laboratories Private Limited, a sterile drug manufacturer in Derabassi, India, was cited for significant deficiencies in its quality system. The inspection revealed failures in establishing and following procedures to prevent microbiological contamination, inadequate production and process controls, and a lack of proper validation for manufacturing processes. Additionally, the firm was found to have deficient cleaning and disinfection systems in aseptic processing areas and inconsistent record-keeping for investigations into discrepancies.

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## Related Officers

- [MARCELLINN D. DORCINVIL](https://www.globalkeysolutions.net/people/marcellinn-d-dorcinvil/213b1d98-0816-4dda-b1ce-491cb6fe29ef)

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