Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
3 Jun 2022
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Yvins Dezan, Ankur C Patel, Jessica S Estriplet
3 Jun 2022
21 CFR 211.188(b)(11)
Identification of persons involved, each significant step
Cited by Yvins Dezan, Ankur C Patel, Jessica S Estriplet
3 Jun 2022
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Yvins Dezan, Ankur C Patel, Jessica S Estriplet
3 Jun 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Yvins Dezan, Ankur C Patel, Jessica S Estriplet
3 Jun 2022
21 CFR 211.46(b)
Equipment for Environmental Control
Cited by Yvins Dezan, Ankur C Patel, Jessica S Estriplet
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 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | 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 7 observations
The source PDF, 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