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FDA Inspection
•Headstar Medical Products Co., Ltd.•December 15, 2016

Headstar Medical Products Co., Ltd. – FDA Inspection, Dec 15, 2016

Record Details

This FDA Inspection record concerns Headstar Medical Products Co., Ltd., with an inspection on December 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company
Headstar Medical Products Co., Ltd.
Inspection Date
December 15, 2016
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • John A. Sciacchitano (Company Rep)
View Company Profile

ID · 1877d3b0-65ff-4155-8d3e-bcddfdbd7b1f

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
994816
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.100(b)Documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Headstar Medical Products Co., Ltd.

2
DateClassificationOfficeProject area
May 22, 2025Not classifiedOffice of Inspections and Investigations
November 5, 2009VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Headstar Medical Products Co., Ltd.
  • FDA Inspection 1273924 - 2025-05-22
  • FDA Inspection 636134 - 2009-11-05

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