Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-06-01.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 May 2026 – 1 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Oct 2017 – 25 Oct 2017 | Medical Devices & Rad Health | Clean | |
| 1 Jul 2014 – 2 Jul 2014 | Medical Devices & Rad Health | Clean | |
| 1 Sep 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Jun 2026
ISO 13485:2016 Clause 4.1.5
Inadequate monitoring and control over outsourced processes
Cited by Linda Galindo
1 Jun 2026
ISO 13485:2016 Clause 7.1
Planning of product realization not consistent with other QMS processes
Cited by Linda Galindo
1 Jun 2026
ISO 13485:2016 Clause 7.1
Records of risk management activities in product realization not maintained
Cited by Linda Galindo
1 Jun 2026
ISO 13485:2016 Clause 8.2.1
Feedback process procedures not documented
Cited by Linda Galindo
1 Jun 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Linda Galindo
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.1.5 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bioplate Inc's 1 Form 483
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