FDA inspection

PAR Sterile Products LLC: FDA inspection ending Jul 20, 2021

FDA inspection 1149014 · Voluntary Action Indicated (VAI) · Rochester, MI

Key facts

Inspection ID 1149014
Firm PAR Sterile Products LLC
FEI number 1818977
Address 870 Parkdale Rd
City Rochester
State MI
ZIP 48307-1740
Fiscal year 2021
Inspection end date Jul 20, 2021
Classification Voluntary Action Indicated (VAI)
Project area New Drug Evaluation
Product type Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 10–99 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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