Overview
- 3 public-safe observations are available for this inspection.
- 2 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 May 2016
21 CFR 1271.50(a)
Determination based on screening and testing
Cited by Ivan E Reyes, Barbara T Carmichael
3 May 2016
21 CFR 1271.47(a)
Procedures for all other requirements
Cited by Ivan E Reyes, Barbara T Carmichael
Inspected site
BFBoca FertilityBoca Raton, 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 | 2x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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