Overview
- 6 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 6 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Processing: conform to other systems
Cited by Darren S Morgan, Kirk A Dymbrowski, Thomas J Prigge, Dell S Moller, Kelli Wilkinson, Brian P Hendrickson
Cooling water - residual sanitizer (S)
Cited by Darren S Morgan, Kirk A Dymbrowski, Thomas J Prigge, Dell S Moller, Kelli Wilkinson, Brian P Hendrickson
Scheduled process - scientific methods not used
Cited by Darren S Morgan, Kirk A Dymbrowski, Thomas J Prigge, Dell S Moller, Kelli Wilkinson, Brian P Hendrickson
Initial temperature of container contents
Cited by Darren S Morgan, Kirk A Dymbrowski, Thomas J Prigge, Dell S Moller, Kelli Wilkinson, Brian P Hendrickson
Critical factors - no record
Cited by Darren S Morgan, Kirk A Dymbrowski, Thomas J Prigge, Dell S Moller, Kelli Wilkinson, Brian P Hendrickson
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 113.40(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.60(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.83 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.87(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 observations
Every observation in full, 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