FDA inspection

GUANGDONG BIOLIGHT MEDITECH CO., LTD: FDA inspection ending Aug 23, 2012

FDA inspection 801765 · Administrative/Directed Change (ADC) · Zhuhai

Key facts

Inspection ID 801765
Firm GUANGDONG BIOLIGHT MEDITECH CO., LTD
FEI number 3007305624
Address Technology Innovation Coast Hi, No. 2 Innovation First Road; Tech Zone
City Zhuhai
Fiscal year 2012
Inspection end date Aug 23, 2012
Classification Administrative/Directed Change (ADC)
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Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices
Product type Devices
Warning letter 381918

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 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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