Coastal Medical Technologies FDA Record
Coastal Medical Technologies has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Coastal Medical Technologies" is on file.
- Latest inspection
- Apr 25, 2025 · NAI
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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 | 7 | 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 | 2 | 0 | 0 | 0 | 0 |
| 2024 | 3 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 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 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 25, 2025 | Lakewood Ranch, FL | Biologics | No Action Indicated (NAI) | 3017102900 |
| Mar 5, 2025 | Fort Myers, FL | Biologics | No Action Indicated (NAI) | 3017424979 |
| Jun 28, 2024 | Tampa, FL | Biologics | No Action Indicated (NAI) | 3028570323 |
| Jun 27, 2024 | Tampa, FL | Biologics | No Action Indicated (NAI) | 3030291745 |
| Jan 30, 2024 | Tampa, FL | Biologics | No Action Indicated (NAI) | 3014435281 |
| Jun 24, 2022 | St Petersburg, FL | Biologics | No Action Indicated (NAI) | 3016710782 |
| Nov 26, 2018 | Tampa, FL | Biologics | No Action Indicated (NAI) | 3014435281 |
- 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 3017102900 | Lakewood Ranch, FL | 1 | Apr 25, 2025 |
| FEI 3017424979 | Fort Myers, FL | 1 | Mar 5, 2025 |
| FEI 3028570323 | Tampa, FL | 1 | Jun 28, 2024 |
| FEI 3030291745 | Tampa, FL | 1 | Jun 27, 2024 |
| FEI 3014435281 | Tampa, FL | 2 | Jan 30, 2024 |
| FEI 3016710782 | St Petersburg, FL | 1 | Jun 24, 2022 |
Coastal Medical Technologies and the FDA: common questions
Has Coastal Medical Technologies received an FDA warning letter?
No FDA warning letter addressed to the name "Coastal Medical Technologies" 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 Coastal Medical Technologies received an FDA Form 483?
FDA has not published a Form 483 for "Coastal Medical Technologies" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Coastal Medical Technologies?
The most recent FDA inspection on file ended Apr 25, 2025 at Lakewood Ranch, FL and was classified NAI. FDA has 7 inspections of Coastal Medical Technologies on file.
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