Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
19 Jan 2011
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Elisa J Beard, Tamara L Setzer, Nhat-Tuan Q Tran
19 Jan 2011
21 CFR 110.10(b)(4)
Unsecured jewelry
Cited by Elisa J Beard, Tamara L Setzer, Nhat-Tuan Q Tran
19 Jan 2011
21 CFR 110.10(b)(6)
Failure to wear
Cited by Elisa J Beard, Tamara L Setzer, Nhat-Tuan Q Tran
19 Jan 2011
21 CFR 110.20(b)(4)
Floors, walls and ceilings
Cited by Elisa J Beard, Tamara L Setzer, Nhat-Tuan Q Tran
19 Jan 2011
21 CFR 110.35(a)
Cleaning and sanitizing operations
Cited by Elisa J Beard, Tamara L Setzer, Nhat-Tuan Q Tran
Inspected site
HIHaveda, Inc.Fairfield, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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