Josef Betzler Surgical Instruments E.K. FDA Record

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

Josef Betzler Surgical Instruments E.K. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Josef Betzler Surgical Instruments E.K." is on file.

What these totals cover: FDA records filed under the name "Josef Betzler Surgical Instruments E.K." and its spelling variant "Josef Betzler Surgical Instruments E.K".

Latest inspection
Dec 22, 2022 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

2 inspections from Sep 10, 2015 to Dec 22, 2022.

DateSiteProductClassificationFEI
Dec 22, 2022Seitingen-Oberflacht, GermanyDevicesNo Action Indicated (NAI)4442
Sep 10, 2015Seitingen-Oberflacht, GermanyDevicesVoluntary Action Indicated (VAI)4442
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.

FacilityLocationInspectionsLatest
FEI 4442Seitingen-Oberflacht, Germany2Dec 22, 2022

Josef Betzler Surgical Instruments E.K. and the FDA: common questions

Has Josef Betzler Surgical Instruments E.K. received an FDA warning letter?

No FDA warning letter addressed to the name "Josef Betzler Surgical Instruments E.K." 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 Josef Betzler Surgical Instruments E.K. received an FDA Form 483?

FDA has not published a Form 483 for "Josef Betzler Surgical Instruments E.K." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Josef Betzler Surgical Instruments E.K.?

The most recent FDA inspection on file ended Dec 22, 2022 at Seitingen-Oberflacht, Germany and was classified NAI. FDA has 2 inspections of Josef Betzler Surgical Instruments E.K. on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.