Overview
- 6 public-safe observations are available for this inspection.
- 3 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.
25 Apr 2018
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Seema S Singh, Ian A Pilcher
25 Apr 2018
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Seema S Singh, Ian A Pilcher
25 Apr 2018
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Seema S Singh, Ian A Pilcher
25 Apr 2018
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Seema S Singh, Ian A Pilcher
25 Apr 2018
21 CFR 820.70(b)
Production and Process Change Procedures, lack of or Inad.
Cited by Seema S Singh, Ian A Pilcher
Inspected site
AIAbaxis IncUnion City, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 6 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