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.
27 Feb 2025
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Marc A Jackson, Celeta S Coves
Inspected site
SMSeaStar Medical, Inc.Denver, United States
Inspection team
CSCeleta S Coves
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | 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
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- 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