Overview
- 10 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-23.
At a glance
Inspections
10
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Jun 2025 – 23 Jun 2025 | Biologics | Clean | |
| 19 Jul 2022 – 21 Jul 2022 | Biologics | 483 | View 483 → |
| 30 Apr 2018 – 1 May 2018 | Biologics | Clean | |
| 24 Jun 2015 | Biologics | Clean | |
| 26 Jun 2013 – 3 Jul 2013 | Biologics | 483 | View 483 → |
| 30 Mar 2011 | Not recorded | Clean | |
| 7 Aug 2009 | Not recorded | Clean | |
| 28 Mar 2008 | Not recorded | Clean | |
| 29 Jan 2002 | Not recorded | Clean | |
| 28 Nov 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Jul 2013
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Annette Melendez
3 Jul 2013
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Annette Melendez
Investigators
FDA investigators tied to this site in the record.
Annette Melendez3 insp.
Frances L Dejesus2 insp.
Laura E Garcia1 insp.
German Rivera1 insp.
Adaliz Santaliz-Cruz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 630.10(g)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Banco De Sangre Humacao, Inc.'s 2 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