Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-12-02.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Nov 2021 – 2 Dec 2021 | Human Drugs | 483 | View 483 → |
| 2 Jan 2018 – 22 Jan 2018 | Human Drugs | 483 | View 483 → |
| 21 Sep 2015 – 7 Oct 2015 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Dec 2021
FDCA 501(a)(2)(A)
Air flow quality, higher classified area
Cited by Sena G Dissmeyer, Kathleen M Jordan
2 Dec 2021
FDCA 501(a)(2)(A)
Cleanliness, ISO-classified areas
Cited by Sena G Dissmeyer, Kathleen M Jordan
Investigators
FDA investigators tied to this site in the record.
Sena G Dissmeyer1 insp.
Kathleen M Jordan1 insp.
Zakaria I Ganiyu1 insp.
Qin Xu1 insp.
Nebil A Oumer1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cape Drugs' 3 Form 483s
Source PDFs, verbatim observations, 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