Sucampo Pharma, LLC

Form 483

Kobe, -, JapanFEI 3009036781Issued December 16, 2015

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3009036781.

Observations2

Issue DateDecember 16, 2015

StatusNo Warning Letter

Related Inspections3

Establishment Details

Firm: Sucampo Pharma, LLC
Location: Kobe, -, Japan
FEI Number: 3009036781
Product Type: Drugs
Issue Date: December 16, 2015
Country: Japan

Inspection History, 2011 to 2023

NAI1

VAI2

NAI means No Action Indicated. VAI means Voluntary Action Indicated.

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

Sucampo Pharma, LLC FDA Form 483, Kobe, December 16, 2015