Overview
- 20 public-safe observations are available for this inspection.
- 5 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.
7 Sep 2022
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Benjamin J Dastoli
Inspected site
LMLucero Medical LLCRichfield, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 4x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 20 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