Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
5 Mar 2026
ISO 13485:2016 Clause 7.1
Records of risk management activities in product realization not maintained
Cited by Sunita Pandey
5 Mar 2026
ISO 13485:2016 Clause 7.3.9
Requirements for design and development changes not met before implementation
Cited by Sunita Pandey
5 Mar 2026
ISO 13485:2016 Clause 7.4.1
Supplier evaluation and selection criteria do not include required elements
Cited by Sunita Pandey
5 Mar 2026
ISO 13485:2016 Clause 7.4.3
Purchased product verification activities are inadequate
Cited by Sunita Pandey
Inspected site
GLGentuity, LLCSudbury, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.9 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | 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 7 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