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FDA Inspection
•Hadeco, Inc.•June 17, 2026

Hadeco, Inc. – FDA Inspection, Jun 17, 2026

Record Details

This FDA Inspection record concerns Hadeco, Inc., with an inspection on June 17, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Hadeco, Inc.
Inspection Date
June 17, 2026
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Javonica F. Penn (Company Rep)
View Company Profile

ID · 7aed4fbb-8e31-4a1e-b940-663fa0949479

Inspection Facts

Inspection number
1324304
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. ISO 13485:2016 Clause 7.5.6Procedures for validation of processes not documented

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Hadeco, Inc.

2
DateClassificationOfficeProject area
April 10, 2024VAICenter for Devices and Radiological HealthCompliance: Devices
June 28, 2018Not classifiedOffice of Inspections and Investigations
Other documents for Hadeco, Inc.
  • FDA Inspection 1237755 - 2024-04-10
  • FDA Inspection 1061270 - 2018-06-28

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