Overview
- 13 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
12 Jun 2026
21 CFR 113.100(a)
Process records - forms missing information
Cited by Rocio Guzman-Velazquez
12 Jun 2026
21 CFR 113.100(a)(2)
Agitating retorts - condensate bleeder; retort speed
Cited by Rocio Guzman-Velazquez
Inspected site
LDLACTALIS DO BRASIL - COMERCIO IMPORTACAO E EXPORTACAO DE LATICINIOS LTDA.Sete Lagoas, Brazil
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.100(a)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 108.35(c)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.100(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(c)(1)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.60(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.60(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.87(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 13 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