Overview
- 10 public-safe observations are available for this inspection.
- 9 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.
30 Mar 2009
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Stephen R Souza, Catherine J Laufmann, Dennis G Kawabata, Norman Wong
30 Mar 2009
21 CFR 820.50(a)(2)
Supplier oversight
Cited by Stephen R Souza, Catherine J Laufmann, Dennis G Kawabata, Norman Wong
30 Mar 2009
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Stephen R Souza, Catherine J Laufmann, Dennis G Kawabata, Norman Wong
30 Mar 2009
21 CFR 820.70(i)
Software validation for automated processes
Cited by Stephen R Souza, Catherine J Laufmann, Dennis G Kawabata, Norman Wong
30 Mar 2009
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Stephen R Souza, Catherine J Laufmann, Dennis G Kawabata, Norman Wong
Inspected site
PIPhysio-Control, Inc.Redmond, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 observations
Every observation in full, 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