Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
10 Aug 2016
21 CFR 211.68(a)
Written calibration / inspection records not kept
Cited by Joey V Quitania, Nicholas L Hunt
10 Aug 2016
21 CFR 211.84(d)(2)
Component written specification
Cited by Joey V Quitania, Nicholas L Hunt
10 Aug 2016
21 CFR 211.192
Quality control unit review of records
Cited by Joey V Quitania, Nicholas L Hunt
Inspected site
ELEnemeez LLCPhoenix, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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