3589 North Sagamore Parkway
Lafayette, IN 47904
ACell maintains a strict quality assurance program. Patient safety and care is our number one priority and we take great pride in producing high quality, safe, and effective products.
All ACell products are marketed pursuant to 510(k) clearances issued by the U.S. Food and Drug Administration (FDA).
All ACell products are manufactured in compliance with the regulations found at 21 CFR Part 820. Similarly, all ACell products are manufactured, stored and distributed in compliance with all federal, state and local requirements and accreditation standards.
All manufacturing procedures are conducted under stringent controls and distributed devices are assured free of Latex, Mercury, Bisphenol (BPA) and Diethylhexyl phthalate (DEHP).
ACell’s manufacturing facilities are registered with the FDA and are ISO 13485 certified.
Questions regarding quality, safety, or performance on distributed products can be sent to QA@acell.com
Resources that may be helpful regarding ACell’s commitment to quality include:
ACell Quality Policy
ACell and its executive management are fully committed to providing superior extracellular matrix products for improving standard of care and patient quality of life.
Latex Free Letter
ACell products are processed without materials or components containing Latex, Mercury, Bisphenol (BPA) or Diethylhexyl phthalate (DEHP).
ISO 13485 Registration
ACell’s certificate of registration for ISO 13485.
ACell’s certificate of registration for MDSAP.
FDA Registration Indiana
FDA Establishment Registration & Device Listing for Indiana.
FDA Registration Maryland
FDA Establishment Registration & Device Listing for Maryland.