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CeramTec GmbH, Medical Products Division FDA Record

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

Latest inspection NAI · Feb 9, 2023
No warning letters matched by name

Inspections 7

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

CeramTec GmbH, Medical Products Division has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "CeramTec GmbH, Medical Products Division" is on file.

What these totals cover: FDA records filed under the name "CeramTec GmbH, Medical Products Division".

Latest inspection: Feb 9, 2023 · 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	7	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

CeramTec GmbH, Medical Products Division's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

CeramTec GmbH, Medical Products Division: FDA inspections per year

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	1	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	2	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

7 inspections from Apr 29, 2010 to Feb 9, 2023.

Date	Site	Product	Classification	FEI
Feb 9, 2023	Plochingen, Germany	Devices	No Action Indicated (NAI)	3002806653
Feb 16, 2018	Marktredwitz, Germany	Devices	No Action Indicated (NAI)	3001278222
Feb 14, 2018	Plochingen, Germany	Devices	No Action Indicated (NAI)	3002806653
Jun 12, 2015	Marktredwitz, Germany	Devices	No Action Indicated (NAI)	3001278222
Jun 10, 2015	Plochingen, Germany	Devices	No Action Indicated (NAI)	3002806653
Feb 9, 2012	Plochingen, Germany	Devices	No Action Indicated (NAI)	3002806653
Apr 29, 2010	Marktredwitz, Germany	Devices	Voluntary Action Indicated (VAI)	3001278222

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 3002806653	Plochingen, Germany	4	Feb 9, 2023
FEI 3001278222	Marktredwitz, Germany	3	Feb 16, 2018

CeramTec GmbH, Medical Products Division and the FDA: common questions

Has CeramTec GmbH, Medical Products Division received an FDA warning letter?

No FDA warning letter addressed to the name "CeramTec GmbH, Medical Products Division" 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 CeramTec GmbH, Medical Products Division received an FDA Form 483?

FDA has not published a Form 483 for "CeramTec GmbH, Medical Products Division" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect CeramTec GmbH, Medical Products Division?

The most recent FDA inspection on file ended Feb 9, 2023 at Plochingen, Germany and was classified NAI. FDA has 7 inspections of CeramTec GmbH, Medical Products Division on file.

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