Green Spot (Thailand) Ltd. FDA Inspection Record

FEI 3004651512 ยท Inspections, Form 483s, warning letters and import refusals

Green Spot (Thailand) Ltd. is an FDA-inspected facility (FEI 3004651512) located in Pathum Thani, TH. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jun 7, 2019: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 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
1

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
Jun 7, 2019Voluntary Action Indicated (VAI)Process records - forms missing information (21 CFR 113.100(a))
Critical factors - no record (21 CFR 113.100(a))
Process change - increase (21 CFR 108.35(c)(2)(ii))
Jan 28, 2011Voluntary Action Indicated (VAI)Adjusted to agree with TID (21 CFR 113.40(f)(2)(iii))
Process adherence (21 CFR 108.35(c)(3)(i))
Process change reporting to CFSAN (21 CFR 108.35(c)(2)(ii))

Facility details

Company
Green Spot (Thailand) Ltd.
Location
Pathum Thani (TH)
Source
inspections

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