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.
26 Feb 2026
21 CFR 806.10(a)(2)
Report of violation of the Act (see 803.52(e)(9))
Cited by Thomas Siebertz, Sara M Onyango
26 Feb 2026
ISO 13485:2016 Clause 4.1.5
Control over outsourced processes not proportionate to risk
Cited by Thomas Siebertz, Sara M Onyango
26 Feb 2026
ISO 13485:2016 Clause 7.3.7
Design and development validation not performed as planned
Cited by Thomas Siebertz, Sara M Onyango
26 Feb 2026
ISO 13485:2016 Clause 7.3.8
Design and development transfer procedures lack required elements
Cited by Thomas Siebertz, Sara M Onyango
26 Feb 2026
ISO 13485:2016 Clause 7.5.6
Procedures for validation of processes not documented
Cited by Thomas Siebertz, Sara M Onyango
Inspected site
STSUMMA THERAPEUTICS, LLCAllston, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.5 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.7 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.8 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.7 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | 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