Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
20 Mar 2026
ISO 13485:2016 Clause 4.1.1
QMS not documented and maintained adequately
Cited by Elizabeth A Krolczyk
20 Mar 2026
ISO 13485:2016 Clause 4.2.3
Medical device file not established and maintained
Cited by Elizabeth A Krolczyk
20 Mar 2026
ISO 13485:2016 Clause 6.4.1
Work environment requirements and procedures not documented
Cited by Elizabeth A Krolczyk
20 Mar 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Elizabeth A Krolczyk
20 Mar 2026
ISO 13485:2016 Clause 7.3.10
Design and development file does not include or reference required records
Cited by Elizabeth A Krolczyk
Inspected site
RAReprolife America, LLCKingwood, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 4.1.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.2.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.4.1 | 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 7.3.10 | 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 7.5.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.9.1 | 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 10 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