Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-18.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jun 2026 – 18 Jun 2026 | Biologics | Clean | |
| 15 Apr 2024 – 30 Apr 2024 | Biologics | WL | View 483 → |
| 1 Nov 2022 – 4 Nov 2022 | Biologics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Apr 2024
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Ivan E Reyes, Barbara T Carmichael, Nerming V Briones
30 Apr 2024
21 CFR 606.121(c)(2)
Name, address, unique facility identifier
Cited by Ivan E Reyes, Barbara T Carmichael, Nerming V Briones
30 Apr 2024
21 CFR 606.160(a)(1)
Concurrent documentation
Cited by Ivan E Reyes, Barbara T Carmichael, Nerming V Briones
30 Apr 2024
21 CFR 606.160(a)(2)
Determination of lot numbers and supplies
Cited by Ivan E Reyes, Barbara T Carmichael, Nerming V Briones
30 Apr 2024
21 CFR 606.160(d)
Retention period
Cited by Ivan E Reyes, Barbara T Carmichael, Nerming V Briones
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.170(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.40(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.121(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.5(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.5(c)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hemarus LLC's 2 Form 483s
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