Overview
- 1 public-safe observation is available for this inspection.
- 1 structured CFR citation is represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
16 Oct 2023
21 CFR 211.68(b)
Backup data not assured as exact and complete
Cited by Marla A Cassidy, Steven D Banks
Inspected site
ARAmerican Red Cross Blood SvcsDurham, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 1 observation
The source PDF, 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