EuroAPI Italy SRL – FDA 483, Jul 17, 2026
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.
ID · 02aafd7a-91b5-4d15-beb6-1586aaf95ba5
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