East Tennessee Lions Eye Bank FDA Record

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

  • Latest inspection NAI · Nov 14, 2025
  • No warning letters matched by name
Inspections 8 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

East Tennessee Lions Eye Bank has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "East Tennessee Lions Eye Bank" is on file.

What these totals cover: FDA records filed under the name "East Tennessee Lions Eye Bank".

Latest inspection
Nov 14, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections8Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

East Tennessee Lions Eye Bank's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

East Tennessee Lions Eye Bank: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202210000
202100000
202000000
201910000
201800000
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.

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Recent FDA inspections

8 inspections from Oct 15, 2008 to Nov 14, 2025.

DateSiteProductClassificationFEI
Nov 14, 2025Knoxville, TNBiologicsNo Action Indicated (NAI)3002689373
Sep 30, 2022Knoxville, TNBiologicsNo Action Indicated (NAI)3002689373
Aug 30, 2019Knoxville, TNBiologicsNo Action Indicated (NAI)3002689373
Jul 26, 2016Knoxville, TNBiologicsNo Action Indicated (NAI)3002689373
Nov 16, 2015Johnson City, TNBiologicsNo Action Indicated (NAI)3010949709
Nov 22, 2013Knoxville, TNBiologicsNo Action Indicated (NAI)3002689373
May 20, 2011Knoxville, TNBiologicsNo Action Indicated (NAI)3002689373
Oct 15, 2008Knoxville, TNBiologicsNo Action Indicated (NAI)3002689373
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

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002689373Knoxville, TN7Nov 14, 2025
FEI 3010949709Johnson City, TN1Nov 16, 2015

East Tennessee Lions Eye Bank and the FDA: common questions

Has East Tennessee Lions Eye Bank received an FDA warning letter?

No FDA warning letter addressed to the name "East Tennessee Lions Eye Bank" 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 East Tennessee Lions Eye Bank received an FDA Form 483?

FDA has not published a Form 483 for "East Tennessee Lions Eye Bank" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect East Tennessee Lions Eye Bank?

The most recent FDA inspection on file ended Nov 14, 2025 at Knoxville, TN and was classified NAI. FDA has 8 inspections of East Tennessee Lions Eye Bank on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.