Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-28.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 May 2026 – 28 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Oct 2022 – 13 Oct 2022 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Oct 2022
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Mary L Schuckmann
13 Oct 2022
21 CFR 820.90(b)(2)
Product rework procedures, Lack of or inadequate procedures
Cited by Mary L Schuckmann
Investigators
FDA investigators tied to this site in the record.
Edward E Lockwood1 insp.
Mary L Schuckmann1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 8.3.4 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Babyation Inc.'s 2 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