Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
4 Jun 2024
21 CFR 117.135(c)(3)
Sanitation preventive controls - Appropriate (Adequate)
Cited by Jessica M Wooten, Alan Escalona, Dorathy M Eischen, Benjamin P Stewart, Lisa M Marko
4 Jun 2024
21 CFR 117.35(a)
Sanitary operations - Plant maintenance
Cited by Jessica M Wooten, Alan Escalona, Dorathy M Eischen, Benjamin P Stewart, Lisa M Marko
4 Jun 2024
21 CFR 117.40
Equipment and utensils - Design and maintenance
Cited by Jessica M Wooten, Alan Escalona, Dorathy M Eischen, Benjamin P Stewart, Lisa M Marko
Inspected site
CDClassic Delight LLCSaint Marys, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.135(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40 | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 3 observations
The source PDF, 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