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Alta Bates Campus Lab Of Alta Bates Summit Medical Center FDA Record

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

Latest inspection NAI · Nov 13, 2024
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

Alta Bates Campus Lab Of Alta Bates Summit Medical Center has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Alta Bates Campus Lab Of Alta Bates Summit Medical Center" is on file.

What these totals cover: FDA records filed under the name "Alta Bates Campus Lab Of Alta Bates Summit Medical Center".

Latest inspection: Nov 13, 2024 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	8	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Alta Bates Campus Lab Of Alta Bates Summit Medical Center's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Alta Bates Campus Lab Of Alta Bates Summit Medical Center: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	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

8 inspections from Jun 16, 2009 to Nov 13, 2024.

Date	Site	Product	Classification	FEI
Nov 13, 2024	Berkeley, CA	Biologics	No Action Indicated (NAI)	2972308
Jun 7, 2022	Berkeley, CA	Biologics	No Action Indicated (NAI)	2972308
Jul 12, 2018	Berkeley, CA	Biologics	No Action Indicated (NAI)	2972308
Jun 17, 2016	Berkeley, CA	Biologics	Voluntary Action Indicated (VAI)	2972308
Apr 2, 2014	Berkeley, CA	Biologics	Voluntary Action Indicated (VAI)	2972308
Dec 3, 2012	Berkeley, CA	Biologics	No Action Indicated (NAI)	2972308
May 16, 2011	Berkeley, CA	Biologics	No Action Indicated (NAI)	2972308
Jun 16, 2009	Berkeley, CA	Biologics	No Action Indicated (NAI)	2972308

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 2972308	Berkeley, CA	8	Nov 13, 2024

Alta Bates Campus Lab Of Alta Bates Summit Medical Center and the FDA: common questions

Has Alta Bates Campus Lab Of Alta Bates Summit Medical Center received an FDA warning letter?

No FDA warning letter addressed to the name "Alta Bates Campus Lab Of Alta Bates Summit Medical Center" 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 Alta Bates Campus Lab Of Alta Bates Summit Medical Center received an FDA Form 483?

FDA has not published a Form 483 for "Alta Bates Campus Lab Of Alta Bates Summit Medical Center" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Alta Bates Campus Lab Of Alta Bates Summit Medical Center?

The most recent FDA inspection on file ended Nov 13, 2024 at Berkeley, CA and was classified NAI. FDA has 8 inspections of Alta Bates Campus Lab Of Alta Bates Summit Medical Center on file.

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