Coastal Medical Technologies FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

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.

What these totals cover: FDA records filed under the name "Coastal Medical Technologies".

Latest inspection
Apr 25, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections7Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Coastal Medical Technologies's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Coastal Medical Technologies: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 0 inspections020232024: 3 inspections320242025: 2 inspections220252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202520000
202430000
202300000
202210000
202100000
202000000
201900000
201810000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

7 inspections from Nov 26, 2018 to Apr 25, 2025.

DateSiteProductClassificationFEI
Apr 25, 2025Lakewood Ranch, FLBiologicsNo Action Indicated (NAI)3017102900
Mar 5, 2025Fort Myers, FLBiologicsNo Action Indicated (NAI)3017424979
Jun 28, 2024Tampa, FLBiologicsNo Action Indicated (NAI)3028570323
Jun 27, 2024Tampa, FLBiologicsNo Action Indicated (NAI)3030291745
Jan 30, 2024Tampa, FLBiologicsNo Action Indicated (NAI)3014435281
Jun 24, 2022St Petersburg, FLBiologicsNo Action Indicated (NAI)3016710782
Nov 26, 2018Tampa, FLBiologicsNo 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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

6 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3017102900Lakewood Ranch, FL1Apr 25, 2025
FEI 3017424979Fort Myers, FL1Mar 5, 2025
FEI 3028570323Tampa, FL1Jun 28, 2024
FEI 3030291745Tampa, FL1Jun 27, 2024
FEI 3014435281Tampa, FL2Jan 30, 2024
FEI 3016710782St Petersburg, FL1Jun 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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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.