Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
4 Apr 2013
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Torrance J Slayton, Joseph A Mendoza
4 Apr 2013
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Torrance J Slayton, Joseph A Mendoza
4 Apr 2013
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Torrance J Slayton, Joseph A Mendoza
4 Apr 2013
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Torrance J Slayton, Joseph A Mendoza
Inspected site
AHArkansas Home Medical, Inc.Little Rock, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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