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Maitland Labs Of Central Florida FDA Record

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

Latest inspection OAI · Feb 28, 2020
Last warning letter 2021

Inspections 2

2 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Aug 6, 2021

510(k) clearances 0 None on file

Maitland Labs Of Central Florida has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Maitland Labs Of Central Florida, the most recent on Aug 6, 2021. FDA has published 2 Form 483s for Maitland Labs Of Central Florida.

What these totals cover: FDA records filed under the name "Maitland Labs Of Central Florida".

Latest inspection: Feb 28, 2020 · OAI

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	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Maitland Labs Of Central Florida's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Maitland Labs Of Central Florida: FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	0	0	0
2022	0	0	0
2021	0	0	1
2020	1	1	0
2019	1	1	0
2018	0	0	0
2017	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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Maitland Labs Of Central Florida FDA Warning Letters

1 warning letter on Aug 6, 2021.

Issued	Subject	Issuing office	Close-out letter
Aug 6, 2021 · Letter on fda.gov	Compounding Pharmacy/Adulterated Drug Products	Office of Pharmaceutical Quality Operations, Division II

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Maitland Labs Of Central Florida Form 483s

2 Form 483s published by FDA.

Date	Document	FEI
Feb 28, 2020 · Document on fda.gov	483	3013854204
Jun 17, 2019 · Document on fda.gov	483	3013854204

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

2 inspections from Jun 17, 2019 to Feb 28, 2020.

Date	Site	Product	Classification	FEI
Feb 28, 2020	Orlando, FL	Drugs	Official Action Indicated (OAI)	3013854204
Jun 17, 2019	Orlando, FL	Drugs	Official Action Indicated (OAI)	3013854204

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Maitland Labs Of Central Florida: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Aug 10, 2021.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3013854204	Orlando, FL	2	Feb 28, 2020

Maitland Labs Of Central Florida and the FDA: common questions

Has Maitland Labs Of Central Florida received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Maitland Labs Of Central Florida. The most recent is dated Aug 6, 2021, with the subject "Compounding Pharmacy/Adulterated Drug Products".

Has Maitland Labs Of Central Florida received an FDA Form 483?

FDA has published 2 Form 483s for Maitland Labs Of Central Florida in its reading room, the most recent dated Feb 28, 2020. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Maitland Labs Of Central Florida?

The most recent FDA inspection on file ended Feb 28, 2020 at Orlando, FL and was classified OAI. FDA has 2 inspections of Maitland Labs Of Central Florida on file, 2 of them classified OAI (official action indicated).

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