Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 12 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Complaint investigation - hazard determination
Cited by Elizabeth P Mayer, Danny Tuntevski, Liliya V Bubiy, Daniel B Arrecis, Alexandra A Carrico, Ana E Morales, John N Woodall, Rohn R Robertson, Christi L Bellmore, Nicholas E Boyd, Brittany A Mckenzie, Adam M True
Personnel - clean outer garments, protective apparel
Cited by Elizabeth P Mayer, Danny Tuntevski, Liliya V Bubiy, Daniel B Arrecis, Alexandra A Carrico, Ana E Morales, John N Woodall, Rohn R Robertson, Christi L Bellmore, Nicholas E Boyd, Brittany A Mckenzie, Adam M True
Equipment, utensil - clean, sanitize
Cited by Elizabeth P Mayer, Danny Tuntevski, Liliya V Bubiy, Daniel B Arrecis, Alexandra A Carrico, Ana E Morales, John N Woodall, Rohn R Robertson, Christi L Bellmore, Nicholas E Boyd, Brittany A Mckenzie, Adam M True
System of process controls to prevent adulteration
Cited by Elizabeth P Mayer, Danny Tuntevski, Liliya V Bubiy, Daniel B Arrecis, Alexandra A Carrico, Ana E Morales, John N Woodall, Rohn R Robertson, Christi L Bellmore, Nicholas E Boyd, Brittany A Mckenzie, Adam M True
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 106.10(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.100(k)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.55(a) | Cited across public-safe Form 483 observations | 1x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 4 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