FDA Inspection
Lutech Industries IncLutech Industries Inc – FDA Inspection, Oct 12, 2017
Record Details
This FDA Inspection record concerns Lutech Industries Inc, with an inspection on October 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 012986ce-063f-40ac-8c26-afa6576dc76c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028481
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.40(b)Document change records, maintained.
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Other FDA inspections of Lutech Industries Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2025 | NAI | New York District Office | Postmarket Assurance: Medical Devices |
| September 10, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 17, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 18, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Lutech Industries Inc
- FDA Inspection 1266521 - 2025-03-26
- FDA Inspection 1154488 - 2021-09-10
- FDA Inspection 941321 - 2015-07-17
- FDA Inspection 852478 - 2013-10-18
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