Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
12 Jul 2017
21 CFR 111.103
Written procedure quality control operations material review
Cited by Lisa A Bowden
12 Jul 2017
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Lisa A Bowden
12 Jul 2017
21 CFR 111.365(d)
Chemical,microbiological,other test-contaminated components
Cited by Lisa A Bowden
Inspected site
BLBrainAlert, LLCLynnwood, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.55 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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