Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
24 May 2023
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Gregory M Bessette, Nassim Ben Makhlouf
24 May 2023
21 CFR 1030.10(c)(3)(i)
tests--errors and uncertainties accounted for
Cited by Gregory M Bessette, Nassim Ben Makhlouf
24 May 2023
21 CFR 1030.10(c)(3)(iii)
Measurements with tap water container
Cited by Gregory M Bessette, Nassim Ben Makhlouf
Inspected site
SASharp Appliances Ltd.Bangpakong, Thailand
Inspection team
NBNassim Ben Makhlouf
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1010.2(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1030.10(c)(3)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1030.10(c)(3)(iii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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