Overview
- 16 public-safe observations are available for this inspection.
- 15 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
15 May 2009
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Anh Lac, Elisa M Fleming, Martha S Baldwin, Gwendolyn F Anderson
15 May 2009
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Anh Lac, Elisa M Fleming, Martha S Baldwin, Gwendolyn F Anderson
15 May 2009
21 CFR 211.84(d)(2)
Reports of Analysis (Components)
Cited by Anh Lac, Elisa M Fleming, Martha S Baldwin, Gwendolyn F Anderson
15 May 2009
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Anh Lac, Elisa M Fleming, Martha S Baldwin, Gwendolyn F Anderson
15 May 2009
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Anh Lac, Elisa M Fleming, Martha S Baldwin, Gwendolyn F Anderson
Inspected site
ALARG Laboratories, Inc.Dallas, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | 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 16 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