Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
8 Mar 2024
21 CFR 106.30(e)(2)(ii)
Cold storage, in-process and final formula - 45 degrees F
Cited by Elizabeth P Mayer, Bing Lin
8 Mar 2024
21 CFR 106.30(e)(5)
Thermal process - frequency, monitor temperature
Cited by Elizabeth P Mayer, Bing Lin
8 Mar 2024
21 CFR 106.30(g)
Filter - 0.5 micrometer or smaller, compressed gas
Cited by Elizabeth P Mayer, Bing Lin
8 Mar 2024
21 CFR 106.55(a)
System of process controls to prevent adulteration
Cited by Elizabeth P Mayer, Bing Lin
8 Mar 2024
21 CFR 106.91(a)(1)
Production aggregate - test each nutrient, added or premix
Cited by Elizabeth P Mayer, Bing Lin
Inspected site
AFAlter Farmacia, SA dba NutribenMeco, Spain
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 106.30(e)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.30(e)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.55(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.91(a)(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