Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
3 Dec 2010
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Susan E Polifko, Tiffani D Wilson
3 Dec 2010
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Susan E Polifko, Tiffani D Wilson
3 Dec 2010
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Susan E Polifko, Tiffani D Wilson
3 Dec 2010
21 CFR 211.186(a)
Signature and checking of records -- 2 persons
Cited by Susan E Polifko, Tiffani D Wilson
Inspected site
ALARx, LLCGlen Rock, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 5 observations
The source PDF and 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