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DiAgam Societe Anonyme (S.A.) FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection OAI · Dec 18, 2025
No warning letters matched by name

Inspections 3

1 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

DiAgam Societe Anonyme (S.A.) has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "DiAgam Societe Anonyme (S.A.)" is on file. FDA has published 1 Form 483 for DiAgam Societe Anonyme (S.A.).

What these totals cover: FDA records filed under the name "DiAgam Societe Anonyme (S.A.)".

Latest inspection: Dec 18, 2025 · OAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

DiAgam Societe Anonyme (S.A.)'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

DiAgam Societe Anonyme (S.A.): FDA inspections per year

Year	Inspections	OAI
2026	0	0
2025	1	1
2024	0	0
2023	1	0
2022	0	0
2021	0	0
2020	1	0
2019	0	0
2018	0	0
2017	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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DiAgam Societe Anonyme (S.A.) Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Dec 18, 2025 · Document on fda.gov	483	3003749380

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

3 inspections from Feb 20, 2020 to Dec 18, 2025.

Date	Site	Product	Classification	FEI
Dec 18, 2025	Ath, Belgium	Devices	Official Action Indicated (OAI)	3003749380
Jan 12, 2023	Ath, Belgium	Devices	No Action Indicated (NAI)	3003749380
Feb 20, 2020	Ath, Belgium	Devices	Voluntary Action Indicated (VAI)	3003749380

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3003749380	Ath, Belgium	3	Dec 18, 2025

DiAgam Societe Anonyme (S.A.) and the FDA: common questions

Has DiAgam Societe Anonyme (S.A.) received an FDA warning letter?

No FDA warning letter addressed to the name "DiAgam Societe Anonyme (S.A.)" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has DiAgam Societe Anonyme (S.A.) received an FDA Form 483?

FDA has published 1 Form 483 for DiAgam Societe Anonyme (S.A.) in its reading room, the most recent dated Dec 18, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect DiAgam Societe Anonyme (S.A.)?

The most recent FDA inspection on file ended Dec 18, 2025 at Ath, Belgium and was classified OAI. FDA has 3 inspections of DiAgam Societe Anonyme (S.A.) on file, 1 of them classified OAI (official action indicated).

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