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483
•EuroAPI Italy SRL•July 17, 2026

EuroAPI Italy SRL – FDA 483, Jul 17, 2026

Record Details

An FDA inspection of EuroAPI Italy SRL in Brindisi from July 9-17, 2026, revealed significant deficiencies across multiple areas. The most severe findings include widespread data integrity issues, such as manipulating test results, forging data, and improper disposal of original records, alongside a failure to adequately investigate out-of-specification results and notify customers. Additional concerns involved uncleaned production equipment, improper storage and evaluation of reserve samples, and poor building maintenance.

Company
EuroAPI Italy SRL
Inspection date
July 17, 2026
Product type
drugs
Office
Office of Inspections and Investigations
Person
  • Pratik S. Upadhyay
View Company Profile

ID · 02aafd7a-91b5-4d15-beb6-1586aaf95ba5

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