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.
3 Jan 2014
21 CFR 1271.50(b)(2)
Donor testing not negative for CD agents
Cited by Patrice S Hall, Lauren E Skokan Priest
3 Jan 2014
21 CFR 1271.55(b)(1)
Statement re: certified testing lab
Cited by Patrice S Hall, Lauren E Skokan Priest
3 Jan 2014
21 CFR 1271.75(a)(1)
Risk factors, clinical evidence
Cited by Patrice S Hall, Lauren E Skokan Priest
3 Jan 2014
21 CFR 1271.85(a)
Infection with communicable disease agents
Cited by Patrice S Hall, Lauren E Skokan Priest
Inspected site
DFDallas Fertility Center - BaylorDallas, United States
Inspection team
PSPatrice S Hall
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.50(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.85(a) | 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