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Wacker Biotech GmbH — FDA Facility Profile

FEI 3008840280

Wacker Biotech GmbH is an FDA-registered facility (FEI 3008840280) located in Saxony-Anhalt, DE. Registered operations: API MANUFACTURE. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Dec 7, 2023: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 VAI)
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

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
Dec 7, 2023Voluntary Action Indicated (VAI)No citations listed
Sep 6, 2019Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Wacker Biotech GmbH
Location
Saxony-Anhalt (DE)
Registration Expires
Dec 31, 2026
Operations
API MANUFACTURE
Source
decrs

FDA data resources

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