Overview
- 8 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.
9 Sep 2009
21 CFR 120.6(a)
Sanitation SSOP - none or not implemented
Cited by Ronald P Boyce, Wen-Jun Peng
9 Sep 2009
21 CFR 120.10(a)
Corrective action - predetermined plan
Cited by Ronald P Boyce, Wen-Jun Peng
Inspected site
DMDel Mar Food Products Corp.Watsonville, United States
Inspection team
WPWen-Jun Peng
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.37(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.10(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.11(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.11(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.24(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.6(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.6(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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