Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
Process filing
Cited by Natalie J Ayoub, Kevin T Gerrity, Tammy Vasquez Hancock, Durell L Giles
Harborage areas
Cited by Natalie J Ayoub, Kevin T Gerrity, Tammy Vasquez Hancock, Durell L Giles
Storage requirements
Cited by Natalie J Ayoub, Kevin T Gerrity, Tammy Vasquez Hancock, Durell L Giles
Hand drying
Cited by Natalie J Ayoub, Kevin T Gerrity, Tammy Vasquez Hancock, Durell L Giles
Document-equipment date of use, maintain, clean, sanitize
Cited by Natalie J Ayoub, Kevin T Gerrity, Tammy Vasquez Hancock, Durell L Giles
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 108.35(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(c)(2)(iii) | 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