Overview
- 6 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
6 Oct 2025
21 CFR 117.130(a)(1)
Hazard analysis - Identification of hazard
Cited by Rebecca L Mullikin, Jamie R Thompson, Sarah A Palmer, Melissa J Holz
6 Oct 2025
21 CFR 117.135(a)(1)
Allergen preventive controls - Implement
Cited by Rebecca L Mullikin, Jamie R Thompson, Sarah A Palmer, Melissa J Holz
6 Oct 2025
21 CFR 117.135(a)(1)
Process preventive controls - Implement
Cited by Rebecca L Mullikin, Jamie R Thompson, Sarah A Palmer, Melissa J Holz
6 Oct 2025
21 CFR 117.135(a)(1)
Sanitation preventive controls - Identify (Written)
Cited by Rebecca L Mullikin, Jamie R Thompson, Sarah A Palmer, Melissa J Holz
6 Oct 2025
21 CFR 117.165(a)(4)
Process preventive controls - Record review
Cited by Rebecca L Mullikin, Jamie R Thompson, Sarah A Palmer, Melissa J Holz
Inspected site
SWSignature Wafers, LLCRipon, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.135(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.165(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.405(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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