Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-07-14.
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 |
|---|---|---|---|
| 6 Jul 2023 – 14 Jul 2023 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Jul 2023
FDCA 501(a)(2)(A)
Lack of disinfection, equipment/supplies from lower to higher quality air
Cited by Sena G Dissmeyer, Tekalign Wondimu
14 Jul 2023
FDCA 501(a)(2)(A)
Personnel, blocked or disrupted first air
Cited by Sena G Dissmeyer, Tekalign Wondimu
14 Jul 2023
FDCA 501(a)(2)(A)
Personnel exposure during aseptic manipulations
Cited by Sena G Dissmeyer, Tekalign Wondimu
Investigators
FDA investigators tied to this site in the record.
Sena G Dissmeyer1 insp.
Tekalign Wondimu1 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 | 5x |
Full site report
Get the verbatim findings behind this site'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