Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
3 Jun 2021
21 CFR 114.100(b)
Maintenance of processing and production records
Cited by Jason P Aun, Robert J Goldman
3 Jun 2021
21 CFR 120.24(c)
Process controls - not exempt, single facility
Cited by Jason P Aun, Robert J Goldman
Inspected site
H&H & H Products CompanyOrlando, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 108.25(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.24(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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