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.
29 Oct 2013
21 CFR 110.80(a)(1)
Inspection of containers and carriers upon receipt
Cited by Leslie A Mendoza, Adaliz Santaliz-Cruz
29 Oct 2013
21 CFR 111.15(e)(1)
Water supply - not component - suitability
Cited by Leslie A Mendoza, Adaliz Santaliz-Cruz
29 Oct 2013
21 CFR 111.20(h)
Physical plant - screening against pests
Cited by Leslie A Mendoza, Adaliz Santaliz-Cruz
29 Oct 2013
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Leslie A Mendoza, Adaliz Santaliz-Cruz
29 Oct 2013
21 CFR 111.140(b)(1)
QC ops; written procedures; material review, disposition
Cited by Leslie A Mendoza, Adaliz Santaliz-Cruz
Inspected site
V&Vacunda & DesignCamuy, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415(f)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | 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