Amnion LLC is an FDA-registered human tissue establishment in Sterling, Virginia. We manufacture amniotic membrane allografts — AmGraft™, AmGraft™ Plus, AmGraft™ Core, and AmDisc™ — under current good tissue practice (CGTP), 21 CFR Part 1271, within an ISO 13485:2016-certified quality management system. This page lists our registrations, accreditations, and certifications, with the identifiers you can use to verify each one.
Page last reviewed: September 2026.
Registrations, accreditations, and certifications
U.S. Food and Drug Administration (FDA) — Registered Tissue Establishment
Facility Establishment Identifier (FEI): 3017609580
Registered and listed under 21 CFR Part 1271 for amniotic membrane (AmDisc™, AmGraft™, AmGraft™ Plus, AmGraft™ Core); annual registration current. Verify in FDA’s HCT/P Establishment Registration database.
American Association of Tissue Banks (AATB) — Accredited Tissue Bank
Accreditation No. 00377
Issued February 12, 2026; expires February 12, 2029. Verify in the AATB accredited bank directory.
ISO 13485:2016 — Medical devices: Quality management systems
Certificate No. 272926, issued by Amtivo
Expires October 5, 2028. Verify through Amtivo’s certificate register or IAF CertSearch.
Health Canada — Cells, Tissues and Organs (CTO) Establishment Registration
Registration No. 100270
Valid January 1, 2026 through December 31, 2027, under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (SOR/2007-118), covering donor screening, testing, and suitability assessment, retrieval, processing, preservation, quarantine, banking, labelling and packaging, and distribution of amniotic membrane.
FDA Certificate to Foreign Government (CFG)
Certificate No. CT:6XHP-KC9M (Application 1506-25), valid May 18, 2026 through May 17, 2028
Issued by FDA’s Center for Biologics Evaluation and Research for AmDisc™, AmGraft™, and AmGraft™ Plus, certifying that these HCT/Ps may be marketed in and legally exported from the United States. AmGraft™ Core is manufactured under the same process as AmGraft™ and is a member of the AmGraft™ product family. A copy is available to international distributors and regulators on request.
State tissue bank licenses and registrations
In addition to federal registration, Amnion holds tissue bank licenses or registrations in the states that require them for out-of-state distributors:
- California — California Department of Public Health Tissue Bank License, CTB 00082295
- Delaware — Delaware Division of Public Health Tissue Bank Registration
- Florida — Agency for Health Care Administration Tissue Bank License No. 440 (Certificate No. 2326); verify at FloridaHealthFinder.gov
- Illinois — Illinois Department of Public Health Tissue Bank Registration No. 3020
- Maryland — Maryland Department of Health Tissue Bank Permit TB3574
- New York — New York State Department of Health Tissue Bank License, Facility ID 2775 (tissue procurement and processing, amniotic membrane)
- Oregon — Oregon Health Authority Procurement Organization/Tissue Bank Registry
Current license certificates are available on request.
How our products are regulated
Amnion’s amniotic membrane allografts are human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271. They are minimally manipulated, intended for homologous use as a covering, and manufactured under current good tissue practice.
As Section 361 HCT/Ps, these products are not subject to FDA premarket review; they are regulated through establishment registration and listing, donor eligibility requirements, and current good tissue practice. FDA acceptance of an establishment registration does not constitute a determination of compliance or an approval of the HCT/P (21 CFR 1271.27(b)).
FDA inspection
Amnion’s Sterling facility underwent an FDA surveillance inspection from March 24 to April 8, 2026.
Donor screening and tissue recovery
Placental tissue is recovered from consenting mothers following scheduled Cesarean-section delivery, by an AATB-accredited recovery partner. Every donor is screened and tested for relevant communicable disease agents and diseases in accordance with 21 CFR Part 1271 Subpart C and AATB Standards for Tissue Banking. Donor eligibility is determined and documented before any tissue is released to processing.
Processing, sterilization, and release
- Processing: tissue is processed at Amnion’s Sterling, Virginia facility using the AmnioCleanse™ process in controlled environments with continuous environmental monitoring.
- Terminal sterilization: every lot is terminally sterilized by electron beam (e-beam) at an ISO 11137-compliant contract sterilization facility, validated to a sterility assurance level (SAL) of 10⁻⁶.
- Lot release testing: each lot is tested for residual moisture (USP <921>, Karl Fischer) by an independent contract laboratory before release.
- Storage and shelf life: allografts are stored and shipped at room temperature (15–30 °C) with a five-year labeled shelf life supported by validation studies.
- Traceability: every allograft is traceable from donor to recipient through lot and unit identifiers, and each shipment includes a tissue tracking record for the receiving facility.
Quality management system
Amnion maintains an ISO 13485:2016-certified quality management system covering document control, supplier qualification, environmental monitoring, complaint handling, adverse reaction reporting, corrective and preventive action, and internal audit. The system is assessed annually by our certification body and by AATB, and is inspected by FDA.
Adverse reactions and complaints
Amnion investigates every complaint and reports adverse reactions involving communicable disease as required under 21 CFR 1271.350. To report an adverse reaction or product complaint, email info@amnion.net, call (571) 368-6966, or use the contact form.
Documentation available on request
- Certificate of Conformance / tissue tracking record for any lot
- ISO 13485:2016 certificate
- AATB accreditation certificate
- FDA registration summary
- Health Canada CTO registration
- State tissue bank licenses
- Sterilization validation summary
- Instructions for use / package insert for each product
Request documentation through the Contact page. Common questions are answered on our FAQ.