FDA Inspection
Microlight Corporation of AmericaMicrolight Corporation of America – FDA Inspection, Jan 24, 2025
Record Details
This FDA Inspection record concerns Microlight Corporation of America, with an inspection on January 24, 2025, issued by the Dallas District Office, covering medical devices & rad health.
- Inspection Date
- January 24, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · a921a8b5-42fc-4966-9cbe-e39ab160acce
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1251436
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
13- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(f)Design verification - documentation
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Other FDA inspections of Microlight Corporation of America
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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