FDA Inspection 1168949 — Ultimate F/X Lasers And Pyrotechnics LLC
The FDA completed an inspection of Ultimate F/X Lasers And Pyrotechnics LLC on May 5, 2022 in Marengo, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 15 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 5, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Marengo, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5043 | 21 CFR 1010.3(a)(1) | ID label lacks name and address |
| 5044 | 21 CFR 1010.3(a)(2) | ID label lacks place, month & year of manufacture |
| 5144 | 21 CFR 1040.10(f)(2)(i) | Safety interlock not provided |
| 5150 | 21 CFR 1040.10(f)(3) | Remote interlock connector |
| 5151 | 21 CFR 1040.10(f)(4) | Key control |
| 5153 | 21 CFR 1040.10(f)(5)(ii) | Emission indicator - Class IIIb & IV |
| 5170 | 21 CFR 1040.10(g)(2)(iii) | Class IIIb "Danger" label |
| 5172 | 21 CFR 1040.10(g)(4) | Logotype label output information |
| 5173 | 21 CFR 1040.10(g)(5)(i) | Aperture label - laser radiation |
| 5180 | 21 CFR 1040.10(g)(6)(iv) | NIPH label wording - Class IIIb |
| 5204 | 21 CFR 1040.10(h)(2)(ii) | Controls, maintenance |
| 5810 | 21 CFR 1002.30(b)(2) | Received from dealers or distributors |
| 5811 | 21 CFR 1002.30(a)(1) | Quality control procedures |