Seko Sp. Z O.O. FDA Record

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

Seko Sp. Z O.O. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Seko Sp. Z O.O." is on file.

What these totals cover: FDA records filed under the name "Seko Sp. Z O.O." and its spelling variant "Seko Sp. Z O.O".

Latest inspection
Jan 28, 2020 · VAI

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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
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

2 inspections from Dec 13, 2011 to Jan 28, 2020.

DateSiteProductClassificationFEI
Jan 28, 2020Chojnice, PolandFood/CosmeticsVoluntary Action Indicated (VAI)3004826726
Dec 13, 2011Chojnice, PolandFood/CosmeticsOfficial Action Indicated (OAI)3004826726
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 3004826726Chojnice, Poland2Jan 28, 2020

Seko Sp. Z O.O. and the FDA: common questions

Has Seko Sp. Z O.O. received an FDA warning letter?

No FDA warning letter addressed to the name "Seko Sp. Z O.O." 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 Seko Sp. Z O.O. received an FDA Form 483?

FDA has not published a Form 483 for "Seko Sp. Z O.O." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Seko Sp. Z O.O.?

The most recent FDA inspection on file ended Jan 28, 2020 at Chojnice, Poland and was classified VAI. FDA has 2 inspections of Seko Sp. Z O.O. on file, 1 of them classified OAI (official action indicated).

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