Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
6 Nov 2019
21 CFR 113.60(a)(1)(i)(b)
Required can seam measurements (seam scope)
Cited by Karen M Labounty
Inspected site
MSMacarico, S. A.Praia De Mira, Portugal
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.60(a)(1)(i)(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.60(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.89 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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