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Francis Polansky, M.D., Inc FDA Record

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

Francis Polansky, M.D., Inc has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Francis Polansky, M.D., Inc" is on file.

What these totals cover: FDA records filed under the name "Francis Polansky, M.D., Inc" and its spelling variant "Francis Polansky, M.D".

Latest inspection: Mar 21, 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	4	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

Francis Polansky, M.D., Inc'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	0	0	0	0	0
2020	1	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

4 inspections from Apr 18, 2013 to Mar 21, 2025.

Date	Site	Product	Classification	FEI
Mar 21, 2025	Palo Alto, CA	Biologics	No Action Indicated (NAI)	3009122683
Jan 14, 2020	Palo Alto, CA	Biologics	No Action Indicated (NAI)	3009122683
Jul 8, 2016	Palo Alto, CA	Biologics	Voluntary Action Indicated (VAI)	3009122683
Apr 18, 2013	Palo Alto, CA	Biologics	No Action Indicated (NAI)	3009122683

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 3009122683	Palo Alto, CA	4	Mar 21, 2025

Francis Polansky, M.D., Inc and the FDA: common questions

Has Francis Polansky, M.D., Inc received an FDA warning letter?

No FDA warning letter addressed to the name "Francis Polansky, M.D., Inc" 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 Francis Polansky, M.D., Inc received an FDA Form 483?

FDA has not published a Form 483 for "Francis Polansky, M.D., Inc" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Francis Polansky, M.D., Inc?

The most recent FDA inspection on file ended Mar 21, 2025 at Palo Alto, CA and was classified NAI. FDA has 4 inspections of Francis Polansky, M.D., Inc on file.

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