Astellas Pharma US Inc.

Form 483

Northbrook, Illinois, United StatesFEI 1000036852Issued February 27, 2012

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 1000036852.

Observations2

Issue DateFebruary 27, 2012

StatusNo Warning Letter

Related Inspections10

Establishment Details

Firm: Astellas Pharma US Inc.
Location: Northbrook, Illinois, United States
FEI Number: 1000036852
Product Type: Drugs
Issue Date: February 27, 2012
Country: United States

Inspection History, 2008 to 2026

NAI6

VAI3

OAI1

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

Astellas Pharma US Inc. FDA Form 483, Northbrook, Illinois, February 27, 2012