# FDA 483 - ACS Dobfar S.p.A. - July 04, 2022

Source: https://www.globalkeysolutions.net/records/483/acs-dobfar-spa/6758a971-5a3f-4c24-9a67-426dc1a6d4e2

> FDA 483 for ACS Dobfar S.p.A. on July 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ACS Dobfar S.p.A.
- Inspection Date: 2022-07-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of ACS Dobfar S.p.A. in Tribiano, Milano, Italy, conducted from July 4-8, 2022, revealed significant deficiencies in record-keeping practices. Observations included incomplete batch and laboratory control records, as well as a lack of independent verification for the accuracy of original laboratory data. These issues indicate potential concerns with data integrity and quality control within the facility.

## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.globalkeysolutions.net/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

Company: https://www.globalkeysolutions.net/companies/acs-dobfar-spa/f96488ff-c292-47a6-8bdf-366e3b281e89

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