Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-07-12.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Jun 2017 – 12 Jul 2017 | Foods & Cosmetics | WL | View 483 → |
| 29 Sep 2014 | Foods & Cosmetics | Clean | |
| 6 May 2013 – 13 May 2013 | Foods & Cosmetics | 483 | View 483 → |
| 4 Aug 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.55 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 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 111.365(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | 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(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind BrainAlert, LLC's 2 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat