Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
4 Sep 2018
21 CFR 1010.3(a)(2)
ID label lacks place, month & year of manufacture
Cited by Dennis R Hock
Inspected site
LILightwave International, LLCBridgeville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1002.30(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1010.3(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1010.3(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1010.4(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1040.10(g)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1040.10(h)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 observations
The full inspection record, as Atlas holds it, 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