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Hexal AG FDA Record

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

Hexal AG has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Hexal AG" is on file.

What these totals cover: FDA records filed under the name "Hexal AG" and its spelling variant "Hexal".

Latest inspection: Mar 29, 2018 · NAI

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	4	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

Hexal AG's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	1	0	0	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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Recent FDA inspections

4 inspections from May 6, 2010 to Mar 29, 2018.

Date	Site	Product	Classification	FEI
Mar 29, 2018	Oberhaching, Germany	Drugs	No Action Indicated (NAI)	3011617743
Dec 21, 2017	Holzkirchen, Germany	Drugs	No Action Indicated (NAI)	3003462123
Feb 19, 2016	Holzkirchen, Germany	Drugs	No Action Indicated (NAI)	3003462123
May 6, 2010	Holzkirchen, Germany	Drugs	No Action Indicated (NAI)	3003462123

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

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3011617743	Oberhaching, Germany	1	Mar 29, 2018
FEI 3003462123	Holzkirchen, Germany	3	Dec 21, 2017

Hexal AG and the FDA: common questions

Has Hexal AG received an FDA warning letter?

No FDA warning letter addressed to the name "Hexal AG" 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 Hexal AG received an FDA Form 483?

FDA has not published a Form 483 for "Hexal AG" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Hexal AG?

The most recent FDA inspection on file ended Mar 29, 2018 at Oberhaching, Germany and was classified NAI. FDA has 4 inspections of Hexal AG on file.

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