FDA Inspection
Ultimate F/X Lasers and Pyrotechnics LLCUltimate F/X Lasers and Pyrotechnics LLC – FDA Inspection, May 5, 2022
Record Details
This FDA Inspection record concerns Ultimate F/X Lasers and Pyrotechnics LLC, with an inspection on May 5, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 5, 2022
- Product Type
- Devices
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ID · 1fe8700d-e29c-4eb5-bf6e-0ffa13f13f6b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1168949
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 1040.10(h)(2)(ii)Controls, maintenance
- 21 CFR 1040.10(f)(5)(ii)Emission indicator - Class IIIb & IV
- 21 CFR 1010.3(a)(1)ID label lacks name and address
- 21 CFR 1010.3(a)(2)ID label lacks place, month & year of manufacture
- 21 CFR 1040.10(g)(2)(iii)Class IIIb "Danger" label
- 21 CFR 1040.10(g)(4)Logotype label output information
- 21 CFR 1040.10(f)(2)(i)Safety interlock not provided
- 21 CFR 1040.10(f)(4)Key control
- 21 CFR 1040.10(f)(3)Remote interlock connector
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