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Rentschler Biopharma SE FDA Inspection Record

FEI 1000291122 · Inspections, Form 483s, warning letters and import refusals

Rentschler Biopharma SE is an FDA-registered facility (FEI 1000291122) located in Baden-Wuerttemberg D-88471, DE. Registered operations: ANALYSIS; API MANUFACTURE; MANUFACTURE. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
May 5, 2023: Voluntary Action Indicated (VAI)
Inspections on record
7 (6 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents
2 in FDA's reading room
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
May 5, 2023Voluntary Action Indicated (VAI)No citations listed
Feb 26, 2021Voluntary Action Indicated (VAI)No citations listed
Aug 9, 2019No Action Indicated (NAI)No citations listed
Dec 6, 2016Voluntary Action Indicated (VAI)Equipment Design, Size and Location (21 CFR 211.63)
Jun 16, 2015Voluntary Action Indicated (VAI)No citations listed
Sep 20, 2013Voluntary Action Indicated (VAI)No citations listed
Jul 19, 2011Voluntary Action Indicated (VAI)No citations listed

Form 483s and inspection documents

  • 483 on FDA.gov
    Inspection Feb 27, 2023 to Mar 7, 2023, issued Mar 7, 2023 (dates printed on the document). FDA listing date Mar 7, 2023. Published by FDA May 5, 2023.
  • 483 on FDA.gov
    Issued Feb 15, 2022 (dates printed on the document). FDA listing date Feb 15, 2022. Published by FDA Jun 10, 2022.

FDA record score

7 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

6 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMay 5, 20236 x 0.63.6
Inspection classified VAIFeb 26, 20216 x 0.251.5
Inspection classified VAIDec 6, 20166 x 0.251.5
Inspection classified VAIJun 16, 201510 years or older, so it adds no points0
Inspection classified VAISep 20, 201310 years or older, so it adds no points0
Inspection classified VAIJul 19, 201110 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Rentschler Biopharma SE
Location
Baden-Wuerttemberg D-88471 (DE)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; API MANUFACTURE; MANUFACTURE
Source
decrs

Import refusals

FDA data resources

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