Labverity
Facility profile

Boiron, Inc.

Drug product manufacturing · Newtown Square, PA

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed4 registered company locations
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

Manufacture
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Oct 25, 2021 · FDA documented observations for voluntary correction.

Matched compliance actions
Warning Letter · Sep 2023

Within five years · review the action and follow-up.

Understand this record

Use the evidence, then ask for fit.

Shows

Registration status and a latest matched voluntary action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

Ask next

Ask what was corrected and review any later inspection or follow-up record.

Method and source details
View full inspection and compliance history3 inspection records

FDA inspection history

3 records, Mar 2011 – Oct 2021 · 2 NAI · 1 VAI · 0 OAI

DateClassProject areaCitationsFY
Oct 25, 2021VAIDrug Quality AssuranceYes2022
Feb 14, 2017NAIDrug Quality Assurance2017
Mar 18, 2011NAIDrug Quality Assurance2011

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

Sep 11, 2023Warning Letter · CDER
Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

Ask about services