Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-05.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Mar 2026 – 5 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Jul 2023 – 14 Jul 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Mar 2014 – 18 Mar 2014 | Medical Devices & Rad Health | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Mar 2026
ISO 13485:2016 Clause 7.1
Records of risk management activities in product realization not maintained
Cited by Yuliana Hernandez-Magana
5 Mar 2026
ISO 13485:2016 Clause 7.3.9
Requirements for design and development changes not met before implementation
Cited by Yuliana Hernandez-Magana
14 Jul 2023
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Olalere D Fasipe
14 Jul 2023
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Olalere D Fasipe
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 820.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.9 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Immuno-Mycologics, Inc's 3 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