Boston University National Emerging Infectious Disease Laboratories FDA Record

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

  • Latest inspection VAI · May 16, 2025
  • No warning letters matched by name
Inspections 1 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Boston University National Emerging Infectious Disease Laboratories has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Boston University National Emerging Infectious Disease Laboratories" is on file.

What these totals cover: FDA records filed under the name "Boston University National Emerging Infectious Disease Laboratories".

Latest inspection
May 16, 2025 · VAI

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
Inspections1Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on May 16, 2025.

DateSiteProductClassificationFEI
May 16, 2025Boston, MADrugsVoluntary Action Indicated (VAI)3003128389
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.

FacilityLocationInspectionsLatest
FEI 3003128389Boston, MA1May 16, 2025

Boston University National Emerging Infectious Disease Laboratories and the FDA: common questions

Has Boston University National Emerging Infectious Disease Laboratories received an FDA warning letter?

No FDA warning letter addressed to the name "Boston University National Emerging Infectious Disease Laboratories" 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 Boston University National Emerging Infectious Disease Laboratories received an FDA Form 483?

FDA has not published a Form 483 for "Boston University National Emerging Infectious Disease Laboratories" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Boston University National Emerging Infectious Disease Laboratories?

The most recent FDA inspection on file ended May 16, 2025 at Boston, MA and was classified VAI. FDA has 1 inspection of Boston University National Emerging Infectious Disease Laboratories on file.

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