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SUCAMPO PHARMA LIMITED LIABILITY COMPANY — FDA Facility Profile

FEI 3009036781

SUCAMPO PHARMA LIMITED LIABILITY COMPANY is an FDA-registered facility (FEI 3009036781) located in Hyogo 650-0047, JP. Registered operations: ANALYSIS. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Sep 27, 2023: No Action Indicated (NAI)
Inspections on record
3 (2 VAI, 1 NAI)
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 27, 2023No Action Indicated (NAI)No citations listed
Dec 16, 2015Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Quality Control Review (21 CFR 211.198(a))
Jul 29, 2011Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Sucampo Pharma, LLC
Location
Hyogo 650-0047 (JP)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS
Source
decrs

FDA data resources

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