Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-13.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Dec 2023 – 13 Dec 2023 | Biologics | 483 | View 483 → |
| 8 Nov 2018 | Biologics | Clean | |
| 16 May 2015 – 17 May 2015 | Biologics | Clean | |
| 14 May 2012 | Not recorded | 483 | View 483 → |
| 20 Feb 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Bobbi J Miller1 insp.
Ramon L Gonzalez-Prieto1 insp.
Everard A Irish1 insp.
Kip J Hanks1 insp.
Decarlos A Gomez1 insp.
Yaw O Osei1 insp.
Lauren E Skokan1 insp.
Ronda R Loyd Jones1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| 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 |
| 21 CFR 1271.85(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat