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Indiana Coast Medical LLC FDA Record

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

Indiana Coast Medical LLC has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Indiana Coast Medical LLC" is on file. FDA has published 1 Form 483 for Indiana Coast Medical LLC.

What these totals cover: FDA records filed under the name "Indiana Coast Medical LLC" and its spelling variant "Indiana Coast Medical".

Latest inspection: Apr 2, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
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	1	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Indiana Coast Medical LLC Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Apr 2, 2025 · Document on fda.gov	483	3019704381

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

1 inspection on Apr 2, 2025.

Date	Site	Product	Classification	FEI
Apr 2, 2025	Valparaiso, IN	Biologics	Voluntary Action Indicated (VAI)	3019704381

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

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3019704381	Valparaiso, IN	1	Apr 2, 2025

Indiana Coast Medical LLC and the FDA: common questions

Has Indiana Coast Medical LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Indiana Coast Medical LLC" 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 Indiana Coast Medical LLC received an FDA Form 483?

FDA has published 1 Form 483 for Indiana Coast Medical LLC in its reading room, the most recent dated Apr 2, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Indiana Coast Medical LLC?

The most recent FDA inspection on file ended Apr 2, 2025 at Valparaiso, IN and was classified VAI. FDA has 1 inspection of Indiana Coast Medical LLC on file.

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