Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-16.
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 |
|---|---|---|---|
| 13 Apr 2026 – 16 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Mar 2023 – 23 Mar 2023 | Medical Devices & Rad Health | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Apr 2026
21 CFR 830.310(b)
GUDID Information required for unique device identification.
Cited by Dennis R Hock, Christina D Mello, Nadia R Barreda
16 Apr 2026
ISO 13485:2016 Clause 5.5.1
Interrelation of personnel not documented
Cited by Dennis R Hock, Christina D Mello, Nadia R Barreda
16 Apr 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Dennis R Hock, Christina D Mello, Nadia R Barreda
16 Apr 2026
ISO 13485:2016 Clause 7.3.7
Design and development validation plans not adequate
Cited by Dennis R Hock, Christina D Mello, Nadia R Barreda
16 Apr 2026
ISO 13485:2016 Clause 7.3.9
Design and development changes not identified
Cited by Dennis R Hock, Christina D Mello, Nadia R Barreda
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 |
|---|---|---|
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 830.310(b) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.5.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.7 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.9 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | 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 Tesla Biohealing, 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