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Blood Assurance Inc. Franklin Donor Center FDA Record

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

Latest inspection NAI · Mar 24, 2026
No warning letters matched by name

Inspections 2

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Blood Assurance Inc. Franklin Donor Center has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Blood Assurance Inc. Franklin Donor Center" is on file.

What these totals cover: FDA records filed under the name "Blood Assurance Inc. Franklin Donor Center".

Latest inspection: Mar 24, 2026 · NAI

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, refresh in progress
Inspections	2	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Blood Assurance Inc. Franklin Donor Center's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Blood Assurance Inc. Franklin Donor Center: FDA inspections per year

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

2 inspections from Oct 7, 2021 to Mar 24, 2026.

Date	Site	Product	Classification	FEI
Mar 24, 2026	Franklin, TN	Biologics	No Action Indicated (NAI)	3019731794
Oct 7, 2021	Franklin, TN	Biologics	No Action Indicated (NAI)	3019731794

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 3019731794	Franklin, TN	2	Mar 24, 2026

Blood Assurance Inc. Franklin Donor Center and the FDA: common questions

Has Blood Assurance Inc. Franklin Donor Center received an FDA warning letter?

No FDA warning letter addressed to the name "Blood Assurance Inc. Franklin Donor Center" 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 Blood Assurance Inc. Franklin Donor Center received an FDA Form 483?

FDA has not published a Form 483 for "Blood Assurance Inc. Franklin Donor Center" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Blood Assurance Inc. Franklin Donor Center?

The most recent FDA inspection on file ended Mar 24, 2026 at Franklin, TN and was classified NAI. FDA has 2 inspections of Blood Assurance Inc. Franklin Donor Center on file.

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