Overview
- 8 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.
13 Dec 2023
21 CFR 1271.50(b)(2)
Donor testing not negative for CD agents
Cited by Bobbi J Miller, Ramon L Gonzalez-Prieto
13 Dec 2023
21 CFR 1271.50(b)(2)
Donor testing not negative for CD agents
Cited by Bobbi J Miller, Ramon L Gonzalez-Prieto
13 Dec 2023
21 CFR 1271.55(d)(1)(iii)
Documentation--determination, by whom, date
Cited by Bobbi J Miller, Ramon L Gonzalez-Prieto
13 Dec 2023
21 CFR 1271.55(d)(1)(iii)
Documentation--determination, by whom, date
Cited by Bobbi J Miller, Ramon L Gonzalez-Prieto
13 Dec 2023
21 CFR 1271.75(a)(1)
Risk factors, clinical evidence
Cited by Bobbi J Miller, Ramon L Gonzalez-Prieto
Inspected site
FAFertility and Advanced Reproductive Medicine at UTSWDallas, United States
Inspection team
BJBobbi J Miller
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 | 2x |
| 21 CFR 1271.55(d)(1)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.90(c) | Cited across public-safe Form 483 observations | 2x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 8 observations
The source PDF, 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