Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
13 May 2013
21 CFR 111.16
Written procedures - pest control
Cited by Christopher R Czajka, Shelagh D Schopen
13 May 2013
21 CFR 111.55
Production, process controls - implement
Cited by Christopher R Czajka, Shelagh D Schopen
13 May 2013
21 CFR 111.70(d)
Specifications - labels, packaging
Cited by Christopher R Czajka, Shelagh D Schopen
13 May 2013
21 CFR 111.83(a)
Reserve sample - collect, hold
Cited by Christopher R Czajka, Shelagh D Schopen
13 May 2013
21 CFR 111.140(b)(1)
Records - quality control operations; responsibilities
Cited by Christopher R Czajka, Shelagh D Schopen
Inspected site
BLBrainAlert, LLCLynnwood, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.16 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.55 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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