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TRANSMARINA PELAGICS — FDA Facility Profile

FEI 3014992691

TRANSMARINA PELAGICS is an FDA-inspected facility (FEI 3014992691) located in Chanduy, EC. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Sep 14, 2019: 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

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 14, 2019Voluntary Action Indicated (VAI)Appropriate quality control operations (21 CFR 117.80(a)(2))
Verification procedures - none/frequency (21 CFR 123.6(c)(6))
Records system (21 CFR 123.6(c)(7))
Critical control points (21 CFR 123.6(c)(2))

Facility details

Company
TRANSMARINA PELAGICS
Location
Chanduy (EC)
Source
inspections

FDA data resources

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