Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-09-22.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Sep 2022 – 22 Sep 2022 | Foods & Cosmetics | Clean | |
| 4 Aug 2021 – 17 Aug 2021 | Foods & Cosmetics | 483 | View 483 → |
| 18 Dec 2018 | Foods & Cosmetics | 483 | View 483 → |
| 31 Mar 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Dec 2018
21 CFR 1.504(b)(1)
Hazard analysis biological, chemical, physical
Cited by Willy A Orantes, Spiridoula Dimopoulos, William Leung
18 Dec 2018
21 CFR 1.505(a)(2)
Evaluation - performance, risk
Cited by Willy A Orantes, Spiridoula Dimopoulos, William Leung
18 Dec 2018
21 CFR 1.505(b)
Supplier approval - document
Cited by Willy A Orantes, Spiridoula Dimopoulos, William Leung
18 Dec 2018
21 CFR 1.506(a)(1)
Procedures - establish, approve supplier
Cited by Willy A Orantes, Spiridoula Dimopoulos, William Leung
Investigators
FDA investigators tied to this site in the record.
Ali A Patino1 insp.
Joseph H Procopio1 insp.
Willy A Orantes1 insp.
Spiridoula Dimopoulos1 insp.
William Leung1 insp.
Peter R Lenahan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.504(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.505(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.505(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(e)(1)(iv)(B) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.510(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fabi-saa Inc.'s 2 Form 483s
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