Bernd Richter GmbH FDA Record

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

  • Latest inspection VAI · Feb 16, 2023
  • No warning letters matched by name
Inspections 1 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Bernd Richter GmbH has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bernd Richter GmbH" is on file.

What these totals cover: FDA records filed under the name "Bernd Richter GmbH" and its spelling variant "Bernd Richter".

Latest inspection
Feb 16, 2023 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections1Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Feb 16, 2023.

DateSiteProductClassificationFEI
Feb 16, 2023Wipperfurth, GermanyDevicesVoluntary Action Indicated (VAI)3004035727
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 3004035727Wipperfurth, Germany1Feb 16, 2023

Bernd Richter GmbH and the FDA: common questions

Has Bernd Richter GmbH received an FDA warning letter?

No FDA warning letter addressed to the name "Bernd Richter GmbH" 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 Bernd Richter GmbH received an FDA Form 483?

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

When did the FDA last inspect Bernd Richter GmbH?

The most recent FDA inspection on file ended Feb 16, 2023 at Wipperfurth, Germany and was classified VAI. FDA has 1 inspection of Bernd Richter GmbH on file.

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