Overview
- 8 public-safe observations are available for this inspection.
- 2 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Cross contamination from people
Cited by Miguel G Manzano, Leslie A Mendoza, Moraima J Ramos-Valle, Ramon A Hernandez
Cross contamination from people
Cited by Miguel G Manzano, Leslie A Mendoza, Moraima J Ramos-Valle, Ramon A Hernandez
Stray animals
Cited by Miguel G Manzano, Leslie A Mendoza, Moraima J Ramos-Valle, Ramon A Hernandez
Stray animals
Cited by Miguel G Manzano, Leslie A Mendoza, Moraima J Ramos-Valle, Ramon A Hernandez
Cross contamination from people
Cited by Miguel G Manzano, Leslie A Mendoza, Moraima J Ramos-Valle, Ramon A Hernandez
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 118.4(b)(3) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 118.4(b)(4) | Cited across public-safe Form 483 observations | 4x |
Full 483 report
Get the verbatim text of all 8 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