Overview
- 14 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-23.
At a glance
Inspections
14
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jul 2024 – 23 Jul 2024 | Biologics | Clean | |
| 11 Mar 2019 – 22 Mar 2019 | Biologics | 483 | View 483 → |
| 6 Mar 2017 – 14 Mar 2017 | Biologics | Clean | |
| 29 Feb 2016 – 11 Mar 2016 | Biologics | 483 | View 483 → |
| 2 Mar 2015 – 16 Mar 2015 | Biologics | 483 | View 483 → |
| 25 Feb 2013 – 8 Mar 2013 | Biologics | 483 | View 483 → |
| 28 Mar 2012 | Not recorded | 483 | View 483 → |
| 26 Mar 2010 | Not recorded | Clean | |
| 13 Mar 2008 | Not recorded | Clean | |
| 20 Apr 2007 | Not recorded | Clean | |
| 9 Apr 2004 | Not recorded | Clean | |
| 13 Mar 2003 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Mar 2019
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Marc A Jackson
Investigators
FDA investigators tied to this site in the record.
Kathryn A Krentz2 insp.
Ava M Bowman2 insp.
Garrad R Poole1 insp.
Marc A Jackson1 insp.
Kip J Hanks1 insp.
Young M Yoon1 insp.
Lauren E Swantko1 insp.
Gloria J Baca1 insp.
Alexander M Kay1 insp.
Dan G Eisenbrey1 insp.
Dolores E Price1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 606.170(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.40(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 630.40(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.140(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.1 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.40(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.6(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.6(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.11(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.34(g)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Blood Bank of Alaska, Inc.'s 5 Form 483s
Source PDFs, 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