Overview
- 4 public-safe observations are available for this inspection.
- 2 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
27 Jan 2025
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Roy Baby, Elizabeth A Krolczyk, Katherine M Thames
27 Jan 2025
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Roy Baby, Elizabeth A Krolczyk, Katherine M Thames
27 Jan 2025
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Roy Baby, Elizabeth A Krolczyk, Katherine M Thames
27 Jan 2025
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Roy Baby, Elizabeth A Krolczyk, Katherine M Thames
Inspected site
ASAcuity Surgical Devices, LLCIrving, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 2x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 4 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