# FDA 483 - Eskayef Pharmaceuticals Limited - April 13, 2022

Source: https://www.globalkeysolutions.net/records/483/eskayef-pharmaceuticals-limited/710f626c-d4c1-489e-8646-66a61fcfc10f

> FDA 483 for Eskayef Pharmaceuticals Limited on April 13, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eskayef Pharmaceuticals Limited
- Inspection Date: 2022-04-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Eskayef Pharmaceuticals Limited, a sterile drug manufacturer in Gazipur, Bangladesh, was cited for significant deficiencies during an FDA inspection. Observations included failures in aseptic processing procedures, inadequate control over computerized systems and data integrity, and scientifically unsound investigations into out-of-specification results. The firm also demonstrated deficiencies in batch record documentation and quality control unit oversight.

## Related Officers

- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.globalkeysolutions.net/companies/eskayef-pharmaceuticals-limited/b4283618-6096-4194-b807-d2ef8302b0b3

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