Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
16 Jan 2025
21 CFR 1.506(a)(1)
Unapproved supplier procedures - importer established
Cited by Gerardo I Martinez
16 Jan 2025
21 CFR 1.506(b)
Supplier verification - follow written procedures
Cited by Gerardo I Martinez
16 Jan 2025
21 CFR 1.506(e)(1)
Verification activity before import, periodically
Cited by Gerardo I Martinez
Inspected site
MUManzela USA, LLCMcallen, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.505(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(e)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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