FacilityLedger

Device establishmentActive, RegisteredFDA warning letter on file

ISOTIS ORTHOBIOLOGICS, INC

ISOTIS ORTHOBIOLOGICS, INC is an FDA-registered device establishment (FEI 3001503333) located in IRVINE, California. The facility is active, registered. Its most recent FDA inspection on record (2025-10-17) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Feb 24, 2026
CGMP/QSR/Medical Devices/Adulterated
Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Recalls (3)

Jul 2, 2026 Class II
Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿
OngoingView source data ›
Nov 27, 2024 Class II
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
OngoingView source data ›
Nov 27, 2024 Class II
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
OngoingView source data ›

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number
3001503333
Address
2 Goodyear, IRVINE, California
Establishment type
Device establishment
Products / operations
Orthopedic, Complaint File Establishment per 21 CFR 820.198, Manufacture Medical Device, Neurology, Develop Specifications But Do Not Manufacture At This Facility, Dental, Manufacture Medical Device for Another Party (Contract Manufacturer)
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Oct 17, 2025 · Official Action Indicated (OAI)
Nov 29, 2017 · No Action Indicated (NAI)
Sep 25, 2015 · No Action Indicated (NAI)
Apr 27, 2012 · No Action Indicated (NAI)
Form 483 observations
Oct 17, 2025, 3 observations: Lack of or inadequate procedures; Process changes - review, evaluation and revalidation; Design Validation - Risk analysis not performed/inadequate

FDA record timeline

Recall
Class II — Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿
Source ›
Warning letter
CGMP/QSR/Medical Devices/Adulterated
Source ›
FDA inspection
OAI classification
Form 483
3 observations
Recall
Class II — Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Source ›
Recall
Class II — Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Source ›
FDA inspection
NAI classification
FDA inspection
NAI classification
FDA inspection
NAI classification

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is ISOTIS ORTHOBIOLOGICS, INC registered with the FDA?

Yes. ISOTIS ORTHOBIOLOGICS, INC is an FDA-registered device establishment (FEI 3001503333) in IRVINE, California. Its current registration status is Active, Registered.

Has ISOTIS ORTHOBIOLOGICS, INC received an FDA warning letter?

Yes. FDA issued a warning letter to ISOTIS ORTHOBIOLOGICS, INC; the most recent is dated Feb 24, 2026 (CGMP/QSR/Medical Devices/Adulterated).

What does ISOTIS ORTHOBIOLOGICS, INC do?

ISOTIS ORTHOBIOLOGICS, INC's FDA-registered operations are: Orthopedic, Complaint File Establishment per 21 CFR 820.198, Manufacture Medical Device, Neurology, Develop Specifications But Do Not Manufacture At This Facility, Dental, Manufacture Medical Device for Another Party (Contract Manufacturer).

Related facilities

Westwood Laboratories, LLC.KC Pharmaceuticals, Inc.Sanitor CorporationImmunityBio, Inc.CellEra, LLCBECKMAN COULTER, INC.

Source: FDA public data · status as of 2026-08-22

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