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Seko Sp. Z O.O. — FDA Facility Profile

FEI 3004826726

Seko Sp. Z O.O. is an FDA-inspected facility (FEI 3004826726) located in Chojnice, PL. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jan 28, 2020: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
Dec 13, 2011
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
Jan 28, 2020Voluntary Action Indicated (VAI)Initial temperature of container contents (21 CFR 113.87(c))
Critical factors not stated (21 CFR 113.83)
Coding - required elements (21 CFR 113.60(c))
Critical control points (21 CFR 123.6(c)(2))
Dec 13, 2011Official Action Indicated (OAI)No citations listed

Facility details

Company
Seko Sp. Z O.O.
Location
Chojnice (PL)
Source
inspections

FDA data resources

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