Overview
- 12 public-safe observations are available for this inspection.
- 4 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.
Personnel - clean outer garments, protective apparel
Cited by Kibily D Dembele, Clara E Santiago, Rene M Amaguana
Personnel - clean outer garments, protective apparel
Cited by Kibily D Dembele, Clara E Santiago, Rene M Amaguana
Maintain building in clean, sanitary condition
Cited by Kibily D Dembele, Clara E Santiago, Rene M Amaguana
Maintain building in clean, sanitary condition
Cited by Kibily D Dembele, Clara E Santiago, Rene M Amaguana
Equipment, utensil - installed to function, clean, maintain
Cited by Kibily D Dembele, Clara E Santiago, Rene M Amaguana
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 106.10(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 106.20(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 106.30(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 106.30(e)(5) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 12 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