ENDO USA, Inc.

Form 483

Issued to: JHP Pharmaceuticals, Inc.

Rochester, Michigan, United StatesFEI 1818977Issued July 23, 2015

View Form 483 PDF

Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1818977.

Observations2

Issue DateJuly 23, 2015

Status1 Related Warning Letter

Establishment TypeManufacturer

Related Inspections10

Establishment Details

Firm: ENDO USA, Inc.
Issued To: JHP Pharmaceuticals, Inc.
Location: Rochester, Michigan, United States
FEI Number: 1818977
Establishment Type: Manufacturer
Product Type: Drugs
Issue Date: July 23, 2015
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.

Act on This Form 483

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ENDO USA, Inc. FDA Form 483, Rochester, Michigan, July 23, 2015