Overview
- 2 public-safe observations are available for this inspection.
- 2 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
NENew England Donor Services, Inc.Waltham, United States
Inspection team
AMAshley M Whitehurst
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.190(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 2 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere