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Carolina Biological Supply Co. FDA Record

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

Carolina Biological Supply Co. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Carolina Biological Supply Co." is on file.

What these totals cover: FDA records filed under the name "Carolina Biological Supply Co." and its spelling variant "Carolina Biological Supply".

Latest inspection: Dec 17, 2025 · NAI
Latest 510(k): Aug 7, 2015

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	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	3	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

Carolina Biological Supply Co.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	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

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.

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Recent FDA inspections

3 inspections from Mar 8, 2018 to Dec 17, 2025.

Date	Site	Product	Classification	FEI
Dec 17, 2025	Burlington, NC	Devices	No Action Indicated (NAI)	1000111286
Sep 23, 2022	Burlington, NC	Devices	Voluntary Action Indicated (VAI)	1000111286
Mar 8, 2018	Burlington, NC	Devices	Voluntary Action Indicated (VAI)	1000111286

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 1000111286	Burlington, NC	3	Dec 17, 2025

Recent 510(k) clearances

1 510(k) clearance on Aug 7, 2015.

K-Number	Device	Date
K140907	LEECH, MEDICINAL	Aug 7, 2015

Carolina Biological Supply Co. and the FDA: common questions

Has Carolina Biological Supply Co. received an FDA warning letter?

No FDA warning letter addressed to the name "Carolina Biological Supply Co." 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 Carolina Biological Supply Co. received an FDA Form 483?

FDA has not published a Form 483 for "Carolina Biological Supply Co." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Carolina Biological Supply Co.?

The most recent FDA inspection on file ended Dec 17, 2025 at Burlington, NC and was classified NAI. FDA has 3 inspections of Carolina Biological Supply Co. on file.

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