ACell, Inc – FDA Warning Letter, Dec 20, 2012

On April 26, 2013, the FDA issued a Warning Letter to ACell, Inc. following an inspection from November 28 to December 20, 2012, at their Columbia, Maryland facility. The inspection revealed that ACell's MatriStem® Surgical Matrix Thick (PSMT) devices are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Key violations include: 1. **Failure to establish and maintain adequate design control procedures (21 CFR § 820.30(a))**: * Lack of rationale for increased design input values (e.g., tensile burst strength). * Incomplete Design History File (DHF) deliverables. * Design validation was not conducted on production equivalents of the device. * The two-year expiration date for Multi-Layer Vacuum Pressed product is not supported by real-time stability data. The firm's use of accelerated aging is deemed inadequate due to the complex nature of the product, requiring real-time data or validated accelerated aging. Stability assessment parameters were also found insufficient, lacking specifications for onset temperature and hydration, and