Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-28.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Jan 2025 – 28 Jan 2025 | Biologics | Clean | |
| 20 Mar 2019 – 22 Mar 2019 | Biologics | Clean | |
| 23 Aug 2016 – 25 Aug 2016 | Biologics | Clean | |
| 26 Jul 2013 – 1 Aug 2013 | Biologics | 483 | View 483 → |
| 15 Oct 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Aug 2013
21 CFR 1271.190(d)(1)
Procedures for cleaning, sanitation
Cited by Kent A Conforti, Ashley M Whitehurst
1 Aug 2013
21 CFR 1271.195(a)(3)
Aseptic processing---cleaning, disinfecting
Cited by Kent A Conforti, Ashley M Whitehurst
Investigators
FDA investigators tied to this site in the record.
Kent A Conforti2 insp.
Jonah S Ufferfilge1 insp.
Alice C Silva1 insp.
Alan R Condon1 insp.
Ashley M Whitehurst1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.190(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.195(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind New England Donor Services, Inc.'s 2 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