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FDA Inspection
•Hi Tech Electronic Manufacturing Corporation•February 6, 2025

Hi Tech Electronic Manufacturing Corporation – FDA Inspection, Feb 6, 2025

Record Details

This FDA Inspection record concerns Hi Tech Electronic Manufacturing Corporation, with an inspection on February 6, 2025, issued by the Los Angeles District Office, covering medical devices & rad health.

Company
Hi Tech Electronic Manufacturing Corporation
Inspection Date
February 6, 2025
Product Type
Medical Devices & Rad Health
Office
Los Angeles District Office
Person
  • Sarah A. Hassas (Company Rep)
View Company Profile

ID · e85850b2-48a4-40b2-88c1-21b23c340257

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1260196
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
  2. 21 CFR 820.184Lack of or inadequate DHR procedures
  3. 21 CFR 820.75(a)Documentation

Full citation text and observation details available on the Dashboard.

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