Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
Effective use of hair restraint
Cited by Jesse A Vazquez, Pablo Alcantara, Patrick E Gainer, Joshua M Adams, Ashley L Reiber, Rafael Padilla, Maria Diaz, Amanda S Zorn, Jeanne J Chiu, Tara C Alcazar, Debra Boyd Seale, Tara M Carolfi
Harborage areas
Cited by Jesse A Vazquez, Pablo Alcantara, Patrick E Gainer, Joshua M Adams, Ashley L Reiber, Rafael Padilla, Maria Diaz, Amanda S Zorn, Jeanne J Chiu, Tara C Alcazar, Debra Boyd Seale, Tara M Carolfi
Floors, walls and ceilings
Cited by Jesse A Vazquez, Pablo Alcantara, Patrick E Gainer, Joshua M Adams, Ashley L Reiber, Rafael Padilla, Maria Diaz, Amanda S Zorn, Jeanne J Chiu, Tara C Alcazar, Debra Boyd Seale, Tara M Carolfi
Safety lighting and glass
Cited by Jesse A Vazquez, Pablo Alcantara, Patrick E Gainer, Joshua M Adams, Ashley L Reiber, Rafael Padilla, Maria Diaz, Amanda S Zorn, Jeanne J Chiu, Tara C Alcazar, Debra Boyd Seale, Tara M Carolfi
Screening
Cited by Jesse A Vazquez, Pablo Alcantara, Patrick E Gainer, Joshua M Adams, Ashley L Reiber, Rafael Padilla, Maria Diaz, Amanda S Zorn, Jeanne J Chiu, Tara C Alcazar, Debra Boyd Seale, Tara M Carolfi
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(7) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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