Jose Fernando Mandujano, M.D. FDA Record
Jose Fernando Mandujano, M.D. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Jose Fernando Mandujano, M.D." is on file.
- Latest inspection
- Aug 11, 2021 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 11, 2021 | Frisco, TX | Biologics | No Action Indicated (NAI) | 3014230512 |
| May 14, 2018 | Frisco, TX | Biologics | Voluntary Action Indicated (VAI) | 3014230512 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3014230512 | Frisco, TX | 2 | Aug 11, 2021 |
Jose Fernando Mandujano, M.D. and the FDA: common questions
Has Jose Fernando Mandujano, M.D. received an FDA warning letter?
No FDA warning letter addressed to the name "Jose Fernando Mandujano, M.D." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Jose Fernando Mandujano, M.D. received an FDA Form 483?
FDA has not published a Form 483 for "Jose Fernando Mandujano, M.D." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Jose Fernando Mandujano, M.D.?
The most recent FDA inspection on file ended Aug 11, 2021 at Frisco, TX and was classified NAI. FDA has 2 inspections of Jose Fernando Mandujano, M.D. on file.
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