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FDA Inspection
•Aid United International Co. Limited•September 29, 2010

Aid United International Co. Limited – FDA Inspection, Sep 29, 2010

Record Details

This FDA Inspection record concerns Aid United International Co. Limited, with an inspection on September 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company
Aid United International Co. Limited
Inspection Date
September 29, 2010
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 62523ad6-0645-4d7e-8304-90fbd8480671

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
694898
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

7
  1. 21 CFR 820.181DMR - not or inadequately maintained
  2. 21 CFR 820.198(a)Complaints
  3. 21 CFR 820.72(a)Equipment control activity documentation
  4. 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
  5. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  6. 21 CFR 820.184DHR content
  7. 21 CFR 803.17Lack of Written MDR Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Aid United International Co. Limited

1
DateClassificationOfficeProject area
September 26, 2023NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Aid United International Co. Limited
  • FDA Inspection 1220787 - 2023-09-26

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