Overview
- 15 public-safe observations are available for this inspection.
- 15 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.
15 May 2026
21 CFR 1271.50(b)(1)
Donor screening standards
Cited by Emily B Camire, Eric Zhu, Abby L Mozeke
15 May 2026
21 CFR 1271.55(a)(3)
Summary--records used to make determination
Cited by Emily B Camire, Eric Zhu, Abby L Mozeke
15 May 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Emily B Camire, Eric Zhu, Abby L Mozeke
15 May 2026
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Emily B Camire, Eric Zhu, Abby L Mozeke
15 May 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Emily B Camire, Eric Zhu, Abby L Mozeke
Inspected site
BCBright Cell IncIrvine, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.50(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.196 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.18(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 15 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