Overview
- 4 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.
14 Dec 2023
21 CFR 117.130(a)(1)
Hazard analysis - Identification of hazard
Cited by Brant M Schroeder, Israel Juarbe, Rowena Trevino-Solis
14 Dec 2023
21 CFR 117.135(a)(1)
Process preventive controls - Identify (Written)
Cited by Brant M Schroeder, Israel Juarbe, Rowena Trevino-Solis
14 Dec 2023
21 CFR 117.135(c)(1)
Process preventive controls - Appropriate (Adequate)
Cited by Brant M Schroeder, Israel Juarbe, Rowena Trevino-Solis
14 Dec 2023
21 CFR 117.37
Sanitary facilities and controls
Cited by Brant M Schroeder, Israel Juarbe, Rowena Trevino-Solis
Inspected site
ASAUSTROFOOD S.A.S.Quito, Ecuador
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.37 | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 4 observations
The source PDF, 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