# FDA 483 - ACS Dobfar SpA - Unknown Date

Source: https://www.keypedia.com/records/483/acs-dobfar-spa/4a7b5e7b-a820-4d20-ae40-8178f3b46d0a

> FDA 483 for ACS Dobfar SpA on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ACS Dobfar SpA
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of ACS Dobfar SpA in Albano S.A. (BG) Italy revealed significant deficiencies in operator qualification and quality control processes. Operators performing critical in-process control testing had not been re-evaluated or re-qualified for years, and one was observed making imprecise measurements during sample preparation. Furthermore, the firm failed to initiate corrective actions for persistent operator error trends identified in 2022 and continuing into 2023, indicating a systemic issue with quality oversight.

## Related Officers

- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

Company: https://www.keypedia.com/companies/acs-dobfar-spa/d02d8bbd-7942-4a5d-a7a8-05fad27d9287

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