Quality Commitment

General Inquiries

6640 Eli Whitney Drive
Columbia, MD 21046
Phone: 800-826-2926

Manufacturing Facility
3589 North Sagamore Parkway
Lafayette, IN 47904
Phone: 765-464-8198

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

Quality Resources

Resources that may be helpful regarding ACell’s commitment to quality include:

ACell Quality Policy

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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

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ACell products are processed without materials or components containing Latex, Mercury, Bisphenol (BPA) or Diethylhexyl phthalate (DEHP).

ISO 13485 Registration

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ACell’s certificate of registration for ISO 13485.

FDA Registration Indiana

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FDA Establishment Registration & Device Listing for Indiana.

FDA Registration Maryland

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FDA Establishment Registration & Device Listing for Maryland.