Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
24 Oct 2013
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by John R Carlson, Kathleen E Mcafoose, Victoria Rosales
24 Oct 2013
21 CFR 110.10(c)
Level of competency (S)
Cited by John R Carlson, Kathleen E Mcafoose, Victoria Rosales
24 Oct 2013
21 CFR 110.20(a)(1)
Harborage areas
Cited by John R Carlson, Kathleen E Mcafoose, Victoria Rosales
24 Oct 2013
21 CFR 110.20(b)(4)
Floors, walls and ceilings
Cited by John R Carlson, Kathleen E Mcafoose, Victoria Rosales
24 Oct 2013
21 CFR 110.20(b)(7)
Screening
Cited by John R Carlson, Kathleen E Mcafoose, Victoria Rosales
Inspected site
QEQuesito El EstabloPeabody, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(5) | 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