Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2021-11-16.
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 |
|---|---|---|---|
| 8 Nov 2021 – 16 Nov 2021 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Nov 2021
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Gamal A Norton, Aigbokhai A Dirisu
16 Nov 2021
21 CFR 820.120
Lack of or inadequate procedures for labeling
Cited by Gamal A Norton, Aigbokhai A Dirisu
16 Nov 2021
21 CFR 820.120(b)
DHR documentation of label release {see also 820.184}
Cited by Gamal A Norton, Aigbokhai A Dirisu
16 Nov 2021
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Gamal A Norton, Aigbokhai A Dirisu
Investigators
FDA investigators tied to this site in the record.
Gamal A Norton1 insp.
Aigbokhai A Dirisu1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kapstone Manufacturing LLC'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