Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-10-16.
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 |
|---|---|---|---|
| 10 Oct 2023 – 16 Oct 2023 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Oct 2023
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Nicole E Knowlton, Damaris Y Hernandez
16 Oct 2023
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Nicole E Knowlton, Damaris Y Hernandez
16 Oct 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Nicole E Knowlton, Damaris Y Hernandez
16 Oct 2023
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Nicole E Knowlton, Damaris Y Hernandez
16 Oct 2023
21 CFR 211.68(b)
Computer control of master formula records
Cited by Nicole E Knowlton, Damaris Y Hernandez
Investigators
FDA investigators tied to this site in the record.
Nicole E Knowlton1 insp.
Damaris Y Hernandez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ultrum Labs, 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