Overview
- 9 public-safe observations are available for this inspection.
- 8 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.
Suitable outer garments
Cited by Sonia R Peterson, Comyar Shoghi, Juanita Banuelos, Nabeela J Chaudhry, Maxyne T Lam, Angelina M Albert
Not washed/sanitized when appropriate
Cited by Sonia R Peterson, Comyar Shoghi, Juanita Banuelos, Nabeela J Chaudhry, Maxyne T Lam, Angelina M Albert
Storage of personal items
Cited by Sonia R Peterson, Comyar Shoghi, Juanita Banuelos, Nabeela J Chaudhry, Maxyne T Lam, Angelina M Albert
Floors, walls and ceilings
Cited by Sonia R Peterson, Comyar Shoghi, Juanita Banuelos, Nabeela J Chaudhry, Maxyne T Lam, Angelina M Albert
Buildings/sanitary
Cited by Sonia R Peterson, Comyar Shoghi, Juanita Banuelos, Nabeela J Chaudhry, Maxyne T Lam, Angelina M Albert
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80 | 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 9 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