Overview
- 12 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
16 Feb 2023
21 CFR 1271.160(b)(6)
Deviations--Investigation, documenting, trending
Cited by Amy A Johnson, Kenneth L Smalls
16 Feb 2023
21 CFR 1271.160(b)(6)
Deviations--Investigation, documenting, trending
Cited by Amy A Johnson, Kenneth L Smalls
16 Feb 2023
21 CFR 1271.160(b)(6)
Deviations--Investigation, documenting, trending
Cited by Amy A Johnson, Kenneth L Smalls
Inspected site
LMLions Medical Eye Bank & Research Center of Eastern VANorfolk, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(b)(6) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.200(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.225 | Cited across public-safe Form 483 observations | 3x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 12 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