Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
5 Feb 2010
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Kenneth Boehnen, Diana L Ayala
5 Feb 2010
21 CFR 1271.47(d)
Departures: recording and justifying
Cited by Kenneth Boehnen, Diana L Ayala
5 Feb 2010
21 CFR 1271.65(b)(2)
Labeled re: biohazard, risks, test results
Cited by Kenneth Boehnen, Diana L Ayala
5 Feb 2010
21 CFR 1271.75(d)
Donors with risks not determined ineligible
Cited by Kenneth Boehnen, Diana L Ayala
Inspected site
IPIVF Phoenix P.L.L.C.Scottsdale, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.47(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.65(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(d) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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