Product Safety
The safety of our products is a foundational value at Medolac. We adhere to Current Good Manufacturing Practices (CGMPs) for food as outlined by the US Food and Drug Administration and other international, federal and local requirements. Our methods, equipment, facilities, and controls for producing processed human milk are structured to meet or exceed those requirements. In States or countries where breast milk products are regulated as human tissue, we will always meet or exceed those requirements as well.
Our safety methods include extensive testing and controls, including considerations outlined in the FDA Working Group on Banked Human Milk.
Our safety methods include extensive testing and controls, including considerations outlined in the FDA Working Group on Banked Human Milk.
- Donor screening requirements at the point of collection including, inter alia, an extensive questionnaire and laboratory blood tests for HIV 1 and 2, HTLV I, II, HAV, HBV, HCV, Syphillis, West Nile Virus and T. cruzi.
- Donor milk test protocols consist of testing for bacteria, viruses, or chemicals (e.g., pharmaceuticals, environmental) intrinsically at the time of collection including total aerobic count, E. coli, Salmonella, Pseudomonas, organisms of fecal origin, B. cereus, Staphylococcus aureus, yeast, mold and 7 drugs of abuse.
- Safety testing of finished product.
Processing, handling and storage of human milk is also closely monitored and controlled throughout the "chain of custody" to guard against tampering, degradation, contamination and spoilage. We use exclusively BPA-free packaging.
Our overriding consideration is to maintain the safety and integrity of donor milk and our adapted donor milk products. We will review our testing requirements on a regular basis to ensure our practices are always best in class.
Our overriding consideration is to maintain the safety and integrity of donor milk and our adapted donor milk products. We will review our testing requirements on a regular basis to ensure our practices are always best in class.
