SGS Analytics Switzerland AG FDA Record

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

SGS Analytics Switzerland AG has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "SGS Analytics Switzerland AG" is on file.

What these totals cover: FDA records filed under the name "SGS Analytics Switzerland AG" and its spelling variant "Sgs Analytics Switzerland".

Latest inspection
Apr 10, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections5Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

SGS Analytics Switzerland AG's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

SGS Analytics Switzerland AG: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 1 inspections120242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202410000
202300000
202200000
202100000
202000000
201910000
201810000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

5 inspections from Oct 24, 2014 to Apr 10, 2025.

DateSiteProductClassificationFEI
Apr 10, 2025Birsfelden, SwitzerlandDrugsVoluntary Action Indicated (VAI)3007178576
Nov 8, 2024Birsfelden, SwitzerlandDrugsNo Action Indicated (NAI)3007178576
Dec 13, 2019Birsfelden, SwitzerlandDrugsNo Action Indicated (NAI)3007178576
Jun 8, 2018Birsfelden, SwitzerlandDrugsNo Action Indicated (NAI)3007178576
Oct 24, 2014Birsfelden, SwitzerlandDrugsNo Action Indicated (NAI)3007178576
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 3007178576Birsfelden, Switzerland5Apr 10, 2025

SGS Analytics Switzerland AG and the FDA: common questions

Has SGS Analytics Switzerland AG received an FDA warning letter?

No FDA warning letter addressed to the name "SGS Analytics Switzerland AG" 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 SGS Analytics Switzerland AG received an FDA Form 483?

FDA has not published a Form 483 for "SGS Analytics Switzerland AG" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect SGS Analytics Switzerland AG?

The most recent FDA inspection on file ended Apr 10, 2025 at Birsfelden, Switzerland and was classified VAI. FDA has 5 inspections of SGS Analytics Switzerland AG on file.

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