Overview
- 21 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Aug 2021
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Jocelyn C Turner
5 Aug 2021
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Jocelyn C Turner
5 Aug 2021
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Jocelyn C Turner
Inspected site
CLCureWave Lasers, LLCDallas, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1010.2(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1040.11(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1040.11(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1040.11(a)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 3x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 21 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere