Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-06-14.
At a glance
Inspections
1
Form 483s
1
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jun 2019 – 14 Jun 2019 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Jun 2019
21 CFR 58.185(a)(9)
Final report: circumstances affecting data qual., integrity
Cited by David L Chon, Anne E Johnson
14 Jun 2019
21 CFR 58.33(e)
Study director: follow GLP regulations
Cited by David L Chon, Anne E Johnson
Investigators
FDA investigators tied to this site in the record.
David L Chon1 insp.
Anne E Johnson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.107 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Johns Hopkins University Laboratory'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