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Sure thing! You can change any of the basic information you want on your account. However, if you alter the shipping address, or the provider information, we will have to re-verify your account before we can ship an order.
Click on the forgot password link on the login screen and follow the directions.
Cancels & Returns
You must cancel an order before it ships. Our shipping center is in Northern Arizona and our time zone is Arizona time. We will have all shipments out the door by 2pm MST.
No returns are allowed. However we can work with you to resolve any problem that occurs.
Product & Process
According to FDA information published in late 2017 a product that is minimally manipulated, and meets homologous use requirements, meets the requirements of a section 361 biologic product. Our product is collected in it’s natural fluid state, is not over manipulated, and meets homologous use requirements for clinical use.
What processes and practices does Amnyo currently have in place to guarantee the safety and efficacy of its products?
Amnyo’s tissue processing follows FDA Good Tissue Practices (GTP), which has a focus on ensuring that the safety and efficacy of the tissues are maintained during processing. Our manufacturing, quality assurance, and final product specifications have been approved by our medical director, who is a board-certified clinical pathologist. Our tissues are tested for sterility per United States Pharmacopoeia USP <71> standards and donors are screened for communicable diseases per 21 CFR 1271.
We have not performed any controlled clinical trials that produce specific safety and efficacy data; however, there have been no reported adverse events attributed to our products to date.
All human tissues used to manufacture our products are sourced from donors who have undergone delivery via scheduled cesarean section and who have been rigorously screened for both medical conditions and social histories. Our tissue recovery partner procures tissues with protocols that follow American Association of Tissue Banks (AATB) standards. Additionally, we have reviewed their recovery, screening, labeling, and shipping protocols and have found them acceptable.
Donor blood is tested for the following communicable diseases per 21 CFR 1271.
- Syphilis (STS)
- Hepatitis B Virus (Surface Ag, Core Ab, NAT)
- Hepatitis C Virus (Ab, NAT)
- Human T-lymphotropic virus, type I (Ab)
- Human T-lymphotropic virus, type II (Ab)
- Human immunodeficiency virus, type O (Ab, NAT)
- Human immunodeficiency virus, type 1 (NAT)
- Human immunodeficiency virus, type 2 (Ab)
- Cytomegalovirus (Ab)
- West Nile Virus (NAT)
Donors are also screened for social histories and high-risk behaviors that may make them a more at-risk demographic for communicable diseases.
What quality controls does Amnyo have in place to address variable collection and processing techniques by its suppliers?
Amniotic fluid is qualitatively assessed before it is accepted (i.e. for color, turbidity, fluid consistency etc.) in addition to review of the serology and social history screening results. Amnyo has partnerships with multiple amniotic fluid suppliers nationwide. Our recovery partners procure the tissues with protocols that adhere to the American Association of Tissue Banks (AATB) standards. Additionally, we have reviewed their collection protocols and have found them acceptable.
Amnyo processes their amniotic fluid products in-house at their laboratory in Flagstaff, Arizona. The lab team is led by a PhD-trained scientist with many years of biologics experience. The facility and their Quality Management System adhere to FDA Good Tissue Practices (GTP).
Still need answers?
Email Amnyo Customer Care with any other questions or suggestions!