Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-10-14.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Oct 2022 – 14 Oct 2022 | Biologics | Clean | |
| 3 May 2018 – 4 May 2018 | Biologics | Clean | |
| 23 Aug 2016 – 24 Aug 2016 | Biologics | Clean | |
| 15 Aug 2013 – 3 Sep 2013 | Biologics | 483 | On file |
| 8 Sep 2011 | Not recorded | 483 | On file |
| 10 Sep 2009 | Not recorded | 483 | On file |
| 28 Nov 2007 | Not recorded | Clean | |
| 14 Feb 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Sep 2013
21 CFR 606.100(c)
Thorough investigations
Cited by Tania Y Hall
8 Sep 2011
21 CFR 606.100(b)(21)
Donor notification
Cited by Tania Y Hall
8 Sep 2011
21 CFR 606.100(c)
Thorough investigations
Cited by Tania Y Hall
10 Sep 2009
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Tania Y Hall
10 Sep 2009
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Tania Y Hall
Investigators
FDA investigators tied to this site in the record.
Tania Y Hall3 insp.
Celeta S Coves1 insp.
Cara M Minelli1 insp.
Laurissa S Flowers1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(21) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind HemaCare Corporation's 3 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