Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-12-16.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Nov 2025 – 16 Dec 2025 | Biologics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Dec 2025
21 CFR 1271.47(a)
Design of procedures to ensure compliance
Cited by Garrad R Poole, Laurissa S Flowers, Emily S Mcgann
16 Dec 2025
21 CFR 1271.50(a)
Responsible person to determine, document
Cited by Garrad R Poole, Laurissa S Flowers, Emily S Mcgann
16 Dec 2025
21 CFR 1271.55(a)(2)
Eligibility statement--basis of determination
Cited by Garrad R Poole, Laurissa S Flowers, Emily S Mcgann
16 Dec 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Garrad R Poole, Laurissa S Flowers, Emily S Mcgann
16 Dec 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Garrad R Poole, Laurissa S Flowers, Emily S Mcgann
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bello Bio LLC's 1 Form 483
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