Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
30 Apr 2026
ISO 13485:2016 Clause 7.3.3
Design and development inputs do not include all requirements
Cited by Suyang Qin
30 Apr 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures lack required elements
Cited by Suyang Qin
30 Apr 2026
ISO 13485:2016 Clause 8.3.1
Procedure for nonconforming product not documented
Cited by Suyang Qin
30 Apr 2026
ISO 13485:2016 Clause 8.4
Procedures for analysis of data not documented
Cited by Suyang Qin
Inspected site
BLBiopoly LlcFort Wayne, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.3.3 | 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 8.3.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.4 | 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