Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
3 Apr 2026
21 CFR 600.15
Blood & Blood Components
Cited by Irina Gaberman, Emily A Walters, Jennifer L Diaz
3 Apr 2026
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Irina Gaberman, Emily A Walters, Jennifer L Diaz
3 Apr 2026
21 CFR 606.160(a)(1)
Concurrent documentation
Cited by Irina Gaberman, Emily A Walters, Jennifer L Diaz
3 Apr 2026
21 CFR 606.160(b)
Required records
Cited by Irina Gaberman, Emily A Walters, Jennifer L Diaz
3 Apr 2026
21 CFR 606.171
Biological product deviation report
Cited by Irina Gaberman, Emily A Walters, Jennifer L Diaz
Inspected site
NYNew York Blood Center EnterprisesRye, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 600.15 | Cited across public-safe Form 483 observations | 1x |
| 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 |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.15(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
The full inspection record, as Atlas holds it, 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