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Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H. FDA Record

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

Latest inspection VAI · May 15, 2025
No warning letters matched by name

Inspections 3

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H." is on file.

What these totals cover: FDA records filed under the name "Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H." and its spelling variant "Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H".

Latest inspection: May 15, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	3	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H.: FDA inspections per year

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

3 inspections from Aug 12, 2021 to May 15, 2025.

Date	Site	Product	Classification	FEI
May 15, 2025	Tornesch, Germany	Drugs	Voluntary Action Indicated (VAI)	3008853092
May 9, 2023	Wedel, Germany	Drugs	Voluntary Action Indicated (VAI)	3005261158
Aug 12, 2021	Tornesch, Germany	Drugs	Voluntary Action Indicated (VAI)	3008853092

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 3008853092	Tornesch, Germany	2	May 15, 2025
FEI 3005261158	Wedel, Germany	1	May 9, 2023

Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H. and the FDA: common questions

Has Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H. received an FDA warning letter?

No FDA warning letter addressed to the name "Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H." 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 Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H. received an FDA Form 483?

FDA has not published a Form 483 for "Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H.?

The most recent FDA inspection on file ended May 15, 2025 at Tornesch, Germany and was classified VAI. FDA has 3 inspections of Medac Gesellschaft Fur Klinische Spezialpraparate M.B.H. on file.

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