Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
3 Apr 2025
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Colin E Tack
3 Apr 2025
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Colin E Tack
3 Apr 2025
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Colin E Tack
Inspected site
L(Lenstec (Barbados) Inc.Christ Church, Barbados
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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