Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
14 Jun 2024
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Cody D Rickman, Meihong Liu, Kaarin M Slotte, Kimberly M Bigler
14 Jun 2024
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Cody D Rickman, Meihong Liu, Kaarin M Slotte, Kimberly M Bigler
14 Jun 2024
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Cody D Rickman, Meihong Liu, Kaarin M Slotte, Kimberly M Bigler
14 Jun 2024
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Cody D Rickman, Meihong Liu, Kaarin M Slotte, Kimberly M Bigler
14 Jun 2024
21 CFR 820.90(a)
Nonconforming product control
Cited by Cody D Rickman, Meihong Liu, Kaarin M Slotte, Kimberly M Bigler
Inspected site
BMBio-Rad Medical Diagnostics GmbHDreieich, Germany
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 5 observations
The source PDF, 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