Overview
- 12 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-26.
At a glance
Inspections
12
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 May 2023 – 26 May 2023 | Biologics | 483 | View 483 → |
| 25 Aug 2021 – 9 Sep 2021 | Biologics | 483 | View 483 → |
| 9 Apr 2018 – 12 Apr 2018 | Biologics | Clean | |
| 16 Mar 2016 – 23 Mar 2016 | Biologics | Clean | |
| 3 Mar 2014 – 12 Mar 2014 | Biologics | Clean | |
| 10 Apr 2012 | Not recorded | 483 | View 483 → |
| 20 Sep 2011 | Not recorded | 483 | View 483 → |
| 4 Feb 2009 | Not recorded | Clean | |
| 30 Mar 2007 | Not recorded | Clean | |
| 29 Jul 2005 | Not recorded | Clean | |
| 12 Dec 2001 | Not recorded | Clean | |
| 30 Dec 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 May 2023
21 CFR 211.68(a)
Written calibration / inspection records not kept
Cited by Sunitha K Rajaram, Kaarin M Slotte
26 May 2023
21 CFR 606.60(a)
Equipment observed, standardized, calibrated
Cited by Sunitha K Rajaram, Kaarin M Slotte
9 Sep 2021
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Peter S Kessler, Paul M Chefor
9 Sep 2021
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Peter S Kessler, Paul M Chefor
Investigators
FDA investigators tied to this site in the record.
Kathryn A Krentz3 insp.
Peter S Kessler2 insp.
Gloria J Baca2 insp.
Sunitha K Rajaram1 insp.
Kaarin M Slotte1 insp.
Paul M Chefor1 insp.
Vanessa Y Jacobs1 insp.
Vanessa Y Gelsey1 insp.
Dianna D Wardlow-Dotter1 insp.
Cynthia L Gorveatt1 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 | 4x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.40(a)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.60(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 630.5(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Tacoma-Pierce County Blood Bank's 4 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