Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
Suitable outer garments
Cited by Joseph S Fanelli, Daniel W Johnson, Brian D Young, Matthew R Noonan
Unsecured jewelry
Cited by Joseph S Fanelli, Daniel W Johnson, Brian D Young, Matthew R Noonan
Precautions against contamination--micro, foreign substances
Cited by Joseph S Fanelli, Daniel W Johnson, Brian D Young, Matthew R Noonan
Cleaning and sanitizing operations
Cited by Joseph S Fanelli, Daniel W Johnson, Brian D Young, Matthew R Noonan
Storage requirements
Cited by Joseph S Fanelli, Daniel W Johnson, Brian D Young, Matthew R Noonan
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(1) | 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)(9) | 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(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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