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FDA inspection

Biocon Sdn Bhd: FDA inspection ending Jul 5, 2019

FDA inspection 1095222 · Official Action Indicated (OAI) · Iskandar Puteri

Key facts

Inspection ID 1095222
Firm Biocon Sdn Bhd
FEI number 3011248248
Address No. 1., Jalan Biooteknologi 1, Kawasan Perindustrian Silc
City Iskandar Puteri
Fiscal year 2019
Inspection end date Jul 5, 2019
Classification Official Action Indicated (OAI)
Project area Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation|Compliance: Medical Devices|New Drug Evaluation
Product type Devices, Drugs

At a glance

  • 10–99 Citations
  • 1–9 Posted citations
  • No 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.

Other inspections at this establishment

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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