Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
24 Mar 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Monica C Burgos Garcia, Lorraine N Williams
24 Mar 2026
ISO 13485:2016 Clause 7.5.1
Production and service provision not adequate
Cited by Monica C Burgos Garcia, Lorraine N Williams
24 Mar 2026
ISO 13485:2016 Clause 8.2.1
Information gathered in feedback process not used as input into risk management
Cited by Monica C Burgos Garcia, Lorraine N Williams
24 Mar 2026
ISO 13485:2016 Clause 8.3.1
Nonconforming product not identified and controlled
Cited by Monica C Burgos Garcia, Lorraine N Williams
24 Mar 2026
ISO 13485:2016 Clause 8.5.2
Corrective action not taken
Cited by Monica C Burgos Garcia, Lorraine N Williams
Inspected site
LCLinvatec Corp.Largo, United States
Inspection team
LNLorraine N Williams
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.1 | 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 8.3.1 | 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 5 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