FDA inspection

Shire Human Genetic Therapies Inc: FDA inspection ending Aug 27, 2008

FDA inspection 533850 · Voluntary Action Indicated (VAI) · Cambridge, MA

Key facts

Inspection ID 533850
Firm Shire Human Genetic Therapies Inc
FEI number 3005955297
Address 205 Alewife Brook Pkwy
City Cambridge
State MA
ZIP 02138-1101
Fiscal year 2008
Inspection end date Aug 27, 2008
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs|Post Mrkt Surv & Epid: Human Drugs
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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