Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-06-07.
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 |
|---|---|---|---|
| 3 Jun 2024 – 7 Jun 2024 | Biologics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Jun 2024
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Tania Y Hall, Lesley Mae P Lutao
7 Jun 2024
21 CFR 1271.50(a)
Determination based on screening and testing
Cited by Tania Y Hall, Lesley Mae P Lutao
7 Jun 2024
21 CFR 1271.55(d)(1)
Documentation maintained (general)
Cited by Tania Y Hall, Lesley Mae P Lutao
7 Jun 2024
21 CFR 1271.75(a)(1)
Risk factors, clinical evidence
Cited by Tania Y Hall, Lesley Mae P Lutao
Investigators
FDA investigators tied to this site in the record.
Tania Y Hall1 insp.
Lesley Mae P Lutao1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cryomate Indiana LLC'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