Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-19.
At a glance
Inspections
9
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Apr 2024 – 19 Apr 2024 | Biologics | 483 | View 483 → |
| 30 Jan 2020 – 5 Feb 2020 | Biologics | Clean | |
| 14 Mar 2019 – 21 Mar 2019 | Biologics | 483 | On file |
| 13 Feb 2017 – 21 Feb 2017 | Biologics | 483 | On file |
| 9 Mar 2015 – 17 Mar 2015 | Biologics | 483 | On file |
| 11 Mar 2013 – 19 Mar 2013 | Biologics | 483 | On file |
| 8 Mar 2011 | Not recorded | 483 | On file |
| 16 Jan 2009 | Not recorded | 483 | On file |
| 19 Jun 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Apr 2024
21 CFR 600.14(a)(1)
Who must report - manufacturer
Cited by Richard T Riggie, Creighton T Tuzon, Elias N Paz Alonzo
19 Apr 2024
21 CFR 803.17(b)(1)
Info evaluated to determine if event was reportable
Cited by Richard T Riggie, Creighton T Tuzon, Elias N Paz Alonzo
19 Apr 2024
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Richard T Riggie, Creighton T Tuzon, Elias N Paz Alonzo
19 Apr 2024
21 CFR 820.150
Lack of or inadequate procedures for storage.
Cited by Richard T Riggie, Creighton T Tuzon, Elias N Paz Alonzo
19 Apr 2024
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Richard T Riggie, Creighton T Tuzon, Elias N Paz Alonzo
Investigators
FDA investigators tied to this site in the record.
Susan M Jackson2 insp.
Richard T Riggie1 insp.
Creighton T Tuzon1 insp.
Elias N Paz Alonzo1 insp.
Priscilla M Pastrana1 insp.
Sharmila Shrestha1 insp.
Prabhu P Raju1 insp.
Debra M Emerson1 insp.
Cynthia Jim1 insp.
Omotunde O Osunsanmi1 insp.
Jacqueline M Diaz Albert1 insp.
Paula A Trost1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 600.14(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind DIAGAST's 7 Form 483s
Source PDFs 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