Source: FDA record for this establishment. FDA publishes inspections or enforcement actions for this establishment, listed further down this page, but we have not matched this particular Form 483 to a document or an inspection date FDA has released. It stays out of the default view for that reason. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1818977.
Observations3
Issue DateJune 08, 2011
Status1 Related Warning Letter
Related Inspections10
Establishment Details
Firm
ENDO USA, Inc.
Location
Rochester, Michigan, United States
FEI Number
1818977
Product Type
Drugs
Issue Date
June 08, 2011
Country
United States
Inspection History, 2012 to 2025
NAI1
VAI8
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.