Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
26 Sep 2025
21 CFR 106.30(a)
Equipment, utensil - installed to function, clean, maintain
Cited by Elizabeth P Mayer, Melissa M Schafer, Megan E Kerry
26 Sep 2025
21 CFR 106.30(e)(2)(ii)
Cold storage, in-process and final formula - 45 degrees F
Cited by Elizabeth P Mayer, Melissa M Schafer, Megan E Kerry
26 Sep 2025
21 CFR 106.30(g)
Filter - 0.5 micrometer or smaller, compressed gas
Cited by Elizabeth P Mayer, Melissa M Schafer, Megan E Kerry
26 Sep 2025
21 CFR 106.35(b)(2)
System input, output - degree, frequency
Cited by Elizabeth P Mayer, Melissa M Schafer, Megan E Kerry
26 Sep 2025
21 CFR 106.50(d)(2)
Controls - spray-drying process
Cited by Elizabeth P Mayer, Melissa M Schafer, Megan E Kerry
Inspected site
SMSynlait Milk LimitedRakaia, New Zealand
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 106.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.30(e)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.50(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.55(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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