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FDA Inspection
•Kawasumi Laboratories (Thailand) Co. Ltd.•March 21, 2018

Kawasumi Laboratories (Thailand) Co. Ltd. – FDA Inspection, Mar 21, 2018

Record Details

This FDA Inspection record concerns Kawasumi Laboratories (Thailand) Co. Ltd., with an inspection on March 21, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Kawasumi Laboratories (Thailand) Co. Ltd.
Inspection Date
March 21, 2018
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Sargum C. Morgan
View Company Profile

ID · 189e232a-19ab-475b-afa3-d22d2259fa1f

Inspection Facts

Inspection number
1045337
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.75(a)Lack of or inadequate process validation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Kawasumi Laboratories (Thailand) Co. Ltd.

2
DateClassificationOfficeProject area
July 25, 2024VAICenter for Devices and Radiological HealthCompliance: Devices
June 21, 2012NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Kawasumi Laboratories (Thailand) Co. Ltd.
  • FDA Inspection 1244549 - 2024-07-25
  • FDA Inspection 787069 - 2012-06-21

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