Antibiotice S.A., Jassi, Romania – FDA Inspections

Inspection records and compliance data for Antibiotice S.A. in Jassi. 5 FDA inspections on record, 1 Form 483, last inspected October 14, 2022.

Company Profile

This profile covers Antibiotice S.A. based in Jassi, Romania.

FDA Inspection History

FDA inspections: 5
OAI: 0
VAI: 4
NAI: 1
Form 483s: 1
Warning letters: 0

First inspected November 9, 2010. Last inspected October 14, 2022.

Most cited issue areas

Cleaning System1 inspection
Environmental Monitoring System1 inspection
Procedures not in writing, fully followed1 inspection

FDA inspections (5)

Date	Result	FDA center(s)	Insp. #
October 14, 2022	VAI	Human Drugs · Drug Quality Assurance	1245118
October 11, 2019	VAI	Human Drugs · Drug Quality Assurance	1136125
March 14, 2017	VAI	Human Drugs · Drug Quality Assurance	1007402
January 22, 2013	NAI	Human Drugs · Drug Quality Assurance	818053
November 9, 2010	VAI	Human Drugs · Drug Quality Assurance	713355

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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