Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-05-15.
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 |
|---|---|---|---|
| 4 May 2026 – 15 May 2026 | Biologics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
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
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 1271.50(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 site report
Get the verbatim findings behind Bright Cell Inc'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