Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-08-16.
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 |
|---|---|---|---|
| 23 Jul 2024 – 16 Aug 2024 | Biologics | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Aug 2024
21 CFR 1271.370(c)(1)
Name, address on label or documentation
Cited by Laurissa S Flowers, Emily B Camire
16 Aug 2024
21 CFR 1271.50(a)
Determination based on screening and testing
Cited by Laurissa S Flowers, Emily B Camire
16 Aug 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Laurissa S Flowers, Emily B Camire
16 Aug 2024
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Laurissa S Flowers, Emily B Camire
16 Aug 2024
21 CFR 211.130(c)
Lot or control number assigned
Cited by Laurissa S Flowers, Emily B Camire
Investigators
FDA investigators tied to this site in the record.
Laurissa S Flowers1 insp.
Emily B Camire1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.370(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.134(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.196 | 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 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Chara Biologics, Inc.'s 1 Form 483
Source PDFs and 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