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Bayer Bitterfeld GmbH FDA Inspection Record

FEI 3003882513 · Inspections, Form 483s, warning letters and import refusals

Bayer Bitterfeld GmbH is an FDA-registered facility (FEI 3003882513) located in Saxony-Anhalt, DE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Jun 19, 2024: Voluntary Action Indicated (VAI)
Inspections on record
5 (4 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
Import refusals
5

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
Jun 19, 2024Voluntary Action Indicated (VAI)No citations listed
Jul 10, 2019No Action Indicated (NAI)No citations listed
Mar 23, 2018Voluntary Action Indicated (VAI)No citations listed
Apr 8, 2016Voluntary Action Indicated (VAI)Equipment Design, Size and Location (21 CFR 211.63)
Backup file not maintained (21 CFR 211.68(b))
Following/documenting laboratory controls (21 CFR 211.160(a))
Investigations of discrepancies, failures (21 CFR 211.192)
and 3 more
Dec 13, 2013Voluntary Action Indicated (VAI)No citations listed

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 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 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Bayer Bitterfeld GmbH
Location
Saxony-Anhalt (DE)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

Import refusals

FDA data resources

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