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483
•ACS Dobfar S.p.A.•July 4, 2022

ACS Dobfar S.p.A. – FDA 483, Jul 4, 2022

Record Details

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.

Company
ACS Dobfar S.p.A.
Inspection date
July 4, 2022
Product type
drugs
Office
Office of Biological Products Operations - Division I
Person
  • Alan P. Kurtzberg (Consumer Safety Officer (Drug Specialist))
View Company Profile

ID · 6758a971-5a3f-4c24-9a67-426dc1a6d4e2

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