Berlimed, S.A., Alcala de Henares, Spain – FDA Inspections

Inspection records and compliance data for Berlimed, S.A. in Alcala de Henares. 6 FDA inspections on record, 2 Form 483s, last inspected April 26, 2024.

Company Profile

This profile covers Berlimed, S.A. based in Alcala de Henares, Spain.

FDA Inspection History

FDA inspections: 6
OAI: 0
VAI: 5
NAI: 0
Unclassified: 1
Form 483s: 2
Warning letters: 0

First inspected June 23, 2009. Last inspected April 26, 2024.

Most cited issue areas

Investigations of discrepancies, failures1 inspection
Scientifically sound laboratory controls1 inspection
Written procedures fail to include1 inspection

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
April 26, 2024	Not classified	Human Drugs	1237531
March 9, 2023	VAI	Human Drugs · Drug Quality Assurance	1268490
March 29, 2019	VAI	Human Drugs · Drug Quality Assurance	1123968
September 25, 2018	VAI	Human Drugs · Drug Quality Assurance	1066603
January 29, 2016	VAI	Human Drugs · Drug Quality Assurance	959549
June 23, 2009	VAI	Human Drugs · Drug Quality Assurance	603530

FDA documents

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

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