Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
CICryomate Indiana LLCIndianapolis, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| 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 483 report
Get the verbatim text of all 8 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere