Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-11-19.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Nov 2025 – 19 Nov 2025 | Medical Devices & Rad Health | Clean | |
| 11 Jul 2023 – 12 Jul 2023 | Medical Devices & Rad Health | Clean | |
| 16 Apr 2018 – 17 Apr 2018 | Medical Devices & Rad Health | Clean | |
| 11 Apr 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Apr 2011
21 CFR 803.17(a)(2)
Lack of System for Determining MDR Events
Cited by Marcelo O Mangalindan, Kinh Q Mac
11 Apr 2011
21 CFR 820.80(d)
Lack of or inadequate final acceptance procedures
Cited by Marcelo O Mangalindan, Kinh Q Mac
11 Apr 2011
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Marcelo O Mangalindan, Kinh Q Mac
Investigators
FDA investigators tied to this site in the record.
Frank J Marciniak1 insp.
Colin E Tack1 insp.
Amy M Cramer1 insp.
Marcelo O Mangalindan1 insp.
Kinh Q Mac1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind EDDA Technology, Inc.'s 1 Form 483
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