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FDA Inspection
•Hugh Steeper Ltd•May 28, 2026

Hugh Steeper Ltd – FDA Inspection, May 28, 2026

Record Details

This FDA Inspection record concerns Hugh Steeper Ltd, with an inspection on May 28, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.

Company
Hugh Steeper Ltd
Inspection Date
May 28, 2026
Product Type
Medical Devices & Rad Health
Office
Center for Devices and Radiological Health
Person
  • Jeffrey J. Thibodeau (FDA Associated Person)
View Company Profile

ID · 327539c2-5357-4fca-be25-f7a88c8a48d2

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1319292
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. ISO 13485:2016 Clause 7.5.4Servicing procedures and reference materials and measurements not documented
  2. 21 CFR 820.35(b)Records of servicing activities do not include required information

Full citation text and observation details available on the Dashboard.

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