Overview
- 11 public-safe observations are available for this inspection.
- 8 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.
2 May 2011
21 CFR 108.35(c)(2)(ii)
Process change - increase
Cited by Brandon J Brookens, Maureen A Wentzel
2 May 2011
21 CFR 108.35(c)(2)(ii)
Process change reporting to CFSAN
Cited by Brandon J Brookens, Maureen A Wentzel
2 May 2011
21 CFR 110.20(b)(4)
Floors, walls and ceilings
Cited by Brandon J Brookens, Maureen A Wentzel
2 May 2011
21 CFR 110.40(a)
Food-contact - unlawful indirect additives
Cited by Brandon J Brookens, Maureen A Wentzel
Inspected site
HFHanover Foods CorporationHanover, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 108.35(c)(2)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.93 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.87(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 11 observations
Every observation in full, 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