Overview
- 24 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
26 Mar 2019
21 CFR 111.420(c)
Repackaged, relabeled - quality control: approve, rejects
Cited by Justin N Henson
26 Mar 2019
21 CFR 111.420(c)
Repackaged, relabeled - quality control: approve, rejects
Cited by Justin N Henson
26 Mar 2019
21 CFR 111.420(c)
Repackaged, relabeled - quality control: approve, rejects
Cited by Justin N Henson
26 Mar 2019
21 CFR 111.70(f)
Specifications - product received for packaging, labeling
Cited by Justin N Henson
26 Mar 2019
21 CFR 111.70(f)
Specifications - product received for packaging, labeling
Cited by Justin N Henson
Inspected site
RTRWM Technologies LLCChattanooga, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.420(c) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.70(f) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 111.75(f)(2) | Cited across public-safe Form 483 observations | 6x |
Full 483 report
Get the verbatim text of all 24 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