# FDA 483 - Kelix bio (Malta) Ltd. - December 16, 2022

Source: https://www.globalkeysolutions.net/records/483/kelix-bio-malta-ltd/865dcc08-1f39-489b-95f0-66be1feb9d04

> FDA 483 for Kelix bio (Malta) Ltd. on December 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kelix bio (Malta) Ltd.
- Inspection Date: 2022-12-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Kelix bio (Malta) Ltd. received a Form 483 following an inspection that identified significant deficiencies in their drug manufacturing processes. Observations included a failure to thoroughly investigate batch discrepancies, inadequately designed equipment for sampling, and deficiencies in aseptic processing area cleaning. Additionally, the firm failed to document established test procedures at the time of performance.

## Related Officers

- [William Leonard](https://www.globalkeysolutions.net/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)

Company: https://www.globalkeysolutions.net/companies/kelix-bio-malta-ltd/3595e81b-9a31-4dcc-b529-e58034aabdf7

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