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.
13 Jul 2017
21 CFR 1271.50(a)
Determination based on screening and testing
Cited by Valerie J Grecek-Trinh, Valerie J Grecek -Trinh
13 Jul 2017
21 CFR 1271.50(a)
Determination based on screening and testing
Cited by Valerie J Grecek-Trinh, Valerie J Grecek -Trinh
13 Jul 2017
21 CFR 1271.75(a)(1)
Risk factors, clinical evidence
Cited by Valerie J Grecek-Trinh, Valerie J Grecek -Trinh
13 Jul 2017
21 CFR 1271.75(a)(1)
Risk factors, clinical evidence
Cited by Valerie J Grecek-Trinh, Valerie J Grecek -Trinh
13 Jul 2017
21 CFR 1271.75(d)
Donors with risks not determined ineligible
Cited by Valerie J Grecek-Trinh, Valerie J Grecek -Trinh
Inspected site
NFNorth Florida Reproductive Biology LaboratoryJacksonville, United States
Inspection team
VJValerie J Grecek -Trinh
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(d) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 6 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