Overview
- 16 public-safe observations are available for this inspection.
- 16 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.
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
Inspected site
BBBello Bio LLCScottsdale, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| 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 483 report
Get the verbatim text of all 16 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