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Pantainorasingh Manufacturer Co., Ltd. — FDA Facility Profile

FEI 3004691124

Pantainorasingh Manufacturer Co., Ltd. is an FDA-inspected facility (FEI 3004691124) located in Muang Samut Sakhon, TH. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
May 25, 2016: 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
10 or more

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
May 25, 2016Voluntary Action Indicated (VAI)Process deviation identification (21 CFR 113.89)
Process adherence (21 CFR 108.35(c)(3)(i))
Dec 18, 2009Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Pantainorasingh Manufacturer Co., Ltd.
Location
Muang Samut Sakhon (TH)
Source
inspections

Import refusals

FDA data resources

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