Overview
- 2 public-safe observations are available for this inspection.
- 2 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
12 Feb 2026
ISO 13485:2016 Clause 8.2.1
Feedback process procedures not documented
Cited by Linda Galindo
12 Feb 2026
ISO 13485:2016 Clause 8.4
Analysis of data not used as input for QMS improvement where necessary
Cited by Linda Galindo
Inspected site
TCTherapak CorporationClaremont, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 8.2.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.4 | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
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Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 2 observations
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