Overview
- 6 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 9 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Sanitation preventive controls - Implement
Cited by Kevin T Gerrity, Charles B Steinmiller, Eric R Holm, Oluwaseyi Ojinni, Jin M Kim, Solomon G Williams, Aryonna M Renouf, Mikayla K Turner, Megan K Rand
Sanitation preventive controls - Implement
Cited by Kevin T Gerrity, Charles B Steinmiller, Eric R Holm, Oluwaseyi Ojinni, Jin M Kim, Solomon G Williams, Aryonna M Renouf, Mikayla K Turner, Megan K Rand
Sanitation preventive controls - Implementation records
Cited by Kevin T Gerrity, Charles B Steinmiller, Eric R Holm, Oluwaseyi Ojinni, Jin M Kim, Solomon G Williams, Aryonna M Renouf, Mikayla K Turner, Megan K Rand
Sanitation preventive controls - Implementation records
Cited by Kevin T Gerrity, Charles B Steinmiller, Eric R Holm, Oluwaseyi Ojinni, Jin M Kim, Solomon G Williams, Aryonna M Renouf, Mikayla K Turner, Megan K Rand
Manufacturing, processing, packing, holding - Controls
Cited by Kevin T Gerrity, Charles B Steinmiller, Eric R Holm, Oluwaseyi Ojinni, Jin M Kim, Solomon G Williams, Aryonna M Renouf, Mikayla K Turner, Megan K Rand
Inspected site
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 | 2x |
| 21 CFR 117.190(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 2x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 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