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FDA Inspection
•DuoProSS Meditech Corporation•July 13, 2018

DuoProSS Meditech Corporation – FDA Inspection, Jul 13, 2018

Record Details

This FDA Inspection record concerns DuoProSS Meditech Corporation, with an inspection on July 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company
DuoProSS Meditech Corporation
Inspection Date
July 13, 2018
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Kwong P. Lee (Company Rep)
View Company Profile

ID · da92356f-2b64-4125-9700-ed9c4fa732fb

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1058782
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 820.198(a)Complaints
  2. 21 CFR 820.100(a)Lack of or inadequate procedures
  3. 21 CFR 803.17Lack of Written MDR Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of DuoProSS Meditech Corporation

2
DateClassificationOfficeProject area
May 22, 2025Not classifiedNew York District Office
August 12, 2022VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for DuoProSS Meditech Corporation
  • FDA Inspection 1275558 - 2025-05-22
  • FDA Inspection 1177699 - 2022-08-12

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