FDA inspection

Shima Laboratories Co., Ltd.: FDA inspection ending Oct 3, 2013

FDA inspection 852209 · Itabashi

Key facts

Inspection ID 852209
Firm Shima Laboratories Co., Ltd.
FEI number 3003985394
Address Itabashi-Ku Tokyo, 1 Chome 16-4; Maeno-Cho
City Itabashi
Fiscal year 2014
Inspection end date Oct 3, 2013
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|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|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 418378

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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