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Laboratorium Soluna Heilmittel Gmbh FDA Inspection Record

FEI 3001614762 · Inspections, Form 483s, warning letters and import refusals

Laboratorium Soluna Heilmittel Gmbh is an FDA-inspected facility (FEI 3001614762) located in Donauworth, DE. RegDataLab tracks 1 FDA inspection at this facility.

What FDA found at this site

Latest inspection
Sep 2, 2016: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 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
Import refusals
10 or more

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
Sep 2, 2016Voluntary Action Indicated (VAI)Approve or reject components, products (21 CFR 211.22(a))
Procedures not in writing, fully followed (21 CFR 211.22(d))
Cleaning/maintenance records not kept (21 CFR 211.67(c))
Computer control of master formula records (21 CFR 211.68(b))
and 7 more

FDA record score

0 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.

2 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAISep 2, 201610 years or older, so it adds no points0
16 import refusals in 2015Dec 31, 201510 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
Laboratorium Soluna Heilmittel Gmbh
Location
Donauworth (DE)
Source
inspections

Import refusals

FDA data resources

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