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AIT Biosciences FDA Record

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

AIT Biosciences has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "AIT Biosciences" is on file.

What these totals cover: FDA records filed under the name "AIT Biosciences".

Latest inspection: Mar 28, 2025 · 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
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

AIT Biosciences'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	0	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	1	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

3 inspections from Jun 28, 2019 to Mar 28, 2025.

Date	Site	Product	Classification	FEI
Mar 28, 2025	Indianapolis, IN	Drugs	No Action Indicated (NAI)	3009546871
Jan 28, 2021	Indianapolis, IN	Drugs	No Action Indicated (NAI)	3009546871
Jun 28, 2019	Indianapolis, IN	Drugs	Voluntary Action Indicated (VAI)	3009546871

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 3009546871	Indianapolis, IN	3	Mar 28, 2025

AIT Biosciences and the FDA: common questions

Has AIT Biosciences received an FDA warning letter?

No FDA warning letter addressed to the name "AIT Biosciences" 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 AIT Biosciences received an FDA Form 483?

FDA has not published a Form 483 for "AIT Biosciences" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect AIT Biosciences?

The most recent FDA inspection on file ended Mar 28, 2025 at Indianapolis, IN and was classified NAI. FDA has 3 inspections of AIT Biosciences on file.

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