FDA inspection

PAR Sterile Products LLC: FDA inspection ending Feb 15, 2001

FDA inspection 62056 · Voluntary Action Indicated (VAI) · Rochester, MI

Key facts

Inspection ID 62056
Firm PAR Sterile Products LLC
FEI number 1818977
Address 870 Parkdale Rd
City Rochester
State MI
ZIP 48307-1740
Fiscal year 2001
Inspection end date Feb 15, 2001
Classification Voluntary Action Indicated (VAI)
Project area Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products|Human Cellular, Tissue, and Gene Therapies|Vaccine, Allergenic, and Live Biotherapeutic Products|Vaccines and Allergenic Products
Product type Biologics, Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes 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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