Regional Womens Health Group LLC, Oradell, NJ – FDA Inspections

Inspection records and compliance data for Regional Womens Health Group LLC in Oradell, New Jersey. 8 FDA inspections on record, last inspected February 11, 2026.

Company Profile

This profile covers Regional Womens Health Group LLC based in Oradell, New Jersey, United States.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 2
NAI: 5
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected April 7, 2009. Last inspected February 11, 2026.

Most cited issue areas

Donor screening standards2 inspections
Determination based on screening and testing1 inspection
Donor testing not negative for CD agents1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
February 11, 2026	Not classified	Biologics	1303160
February 21, 2023	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1198760
September 17, 2019	NAI	Biologics · Blood and Blood Products	1102414
February 15, 2017	NAI	Biologics · Blood and Blood Products	1003951
June 1, 2015	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	929318
February 20, 2013	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	819345
April 13, 2011	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	719288
April 7, 2009	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	577162

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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