Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
9 Apr 2026
ISO 13485:2016 Clause 6.4.1(a)
Requirements for personnel health, cleanliness, and clothing not documented
Cited by Naakesh N Gomanie
9 Apr 2026
ISO 13485:2016 Clause 7.5.7
Processes for sterilization and sterile barrier systems not validated
Cited by Naakesh N Gomanie
9 Apr 2026
ISO 13485:2016 Clause 8.2.5
Monitoring/measurement methods do not show QMS processes meet planned results
Cited by Naakesh N Gomanie
Inspected site
BPBio Protech, Inc.Wonju-Si, Korea (the Republic of)
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 6.4.1(a) | 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 8.2.5 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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