Overview
- 11 public-safe observations are available for this inspection.
- 11 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.
17 May 2012
21 CFR 114.100(a)
Raw materials, packaging, finished product
Cited by Brian R Cronenwett, Audra J Ashmore
17 May 2012
21 CFR 114.100(b)
Maintenance of processing and production records
Cited by Brian R Cronenwett, Audra J Ashmore
Inspected site
PHPersimmon Hill Farm Gourmet Foods, IncLampe, United States
Inspection team
AJAudra J Ashmore
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 114.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.89 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.11(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.11(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.7(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(2) | 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