Overview
- 2 public-safe observations are available for this inspection.
- 2 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.
4 Nov 2022
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Gregory M Bessette, Francis Pham
4 Nov 2022
21 CFR 1030.10(c)(3)(i)
tests--errors and uncertainties accounted for
Cited by Gregory M Bessette, Francis Pham
Inspected site
WUWelbilt U.K. LtdSheffield, United Kingdom
Inspection team
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 |
Full 483 report
Get the verbatim text of all 2 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