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The Medical Center IRB FDA Record

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

Latest inspection OAI · Nov 18, 2009
No warning letters matched by name

Inspections 1

1 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

The Medical Center IRB has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "The Medical Center IRB" is on file.

What these totals cover: FDA records filed under the name "The Medical Center IRB" and its spelling variant "Medical Center Irb". Records filed under related names are not included; see Related names.

Latest inspection: Nov 18, 2009 · OAI

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	1	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for The Medical Center IRB above.

Name	Relation	510(k)	Inspections	Most recent recall
Medical Combines 2 spellings Medical: 22 510(k)s Medical Company: 2 inspections	Same company group	22	2	—
Medical Center At Bowling Green	Same company group	0	5	—
Medical Center Of Aurora	Same company group	0	1	—
Medical Device Group	Same company group	1	0	—
Medical Mommas	Same company group	0	1	—

Recent FDA inspections

1 inspection on Nov 18, 2009.

Date	Site	Product	Classification	FEI
Nov 18, 2009	Beaver, PA	Biologics	Official Action Indicated (OAI)	3007931397

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 3007931397	Beaver, PA	1	Nov 18, 2009

The Medical Center IRB and the FDA: common questions

Has The Medical Center IRB received an FDA warning letter?

No FDA warning letter addressed to the name "The Medical Center IRB" 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 The Medical Center IRB received an FDA Form 483?

FDA has not published a Form 483 for "The Medical Center IRB" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect The Medical Center IRB?

The most recent FDA inspection on file ended Nov 18, 2009 at Beaver, PA and was classified OAI. FDA has 1 inspection of The Medical Center IRB on file, 1 of them classified OAI (official action indicated).

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