Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
31 Aug 2022
21 CFR 1.505(b)
Supplier approval - document
Cited by Shannon A Dinardo, Martha A Forsythe, Amanda F Smith
31 Aug 2022
21 CFR 1.506(a)(1)
Approved supplier procedures - importer established
Cited by Shannon A Dinardo, Martha A Forsythe, Amanda F Smith
31 Aug 2022
21 CFR 1.506(b)
Supplier verification - establish written procedures
Cited by Shannon A Dinardo, Martha A Forsythe, Amanda F Smith
31 Aug 2022
21 CFR 1.506(d)(1)(i)
Verification activity assurance
Cited by Shannon A Dinardo, Martha A Forsythe, Amanda F Smith
31 Aug 2022
21 CFR 1.506(e)(1)
Verification activity before import, periodically
Cited by Shannon A Dinardo, Martha A Forsythe, Amanda F Smith
Inspected site
SGSpeed Global ServicesBuffalo, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.505(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(d)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(e)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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