Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-17.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Apr 2026 – 17 Apr 2026 | Biologics | 483 | On file |
| 2 Jan 2025 – 6 Jan 2025 | Human Drugs | Clean | |
| 27 Jul 2021 – 30 Jul 2021 | Biologics | 483 | On file |
| 25 Jun 2019 – 27 Jun 2019 | Biologics | 483 | On file |
| 25 Jul 2017 – 28 Jul 2017 | Biologics | Clean | |
| 4 May 2017 – 11 May 2017 | Human Drugs | 483 | View 483 → |
| 19 Jun 2014 – 26 Jun 2014 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 May 2017
21 CFR 211.194(a)(8)
Identification of Person Performing Review of Lab Records
Cited by Edmund F Mrak
Investigators
FDA investigators tied to this site in the record.
Burnell M Henry2 insp.
Edmund F Mrak2 insp.
Kent A Conforti1 insp.
Steven E Bowen1 insp.
Jason D Abel1 insp.
Jacqueline M Diaz Albert1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Haematologic Technologies, LLC's 4 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