LifeCell Corporation – FDA Warning Letter, Nov 12, 2010

The FDA issued a Warning Letter to LifeCell Corporation following an inspection from November 2-12, 2010, which identified serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Section 520(g) of the Federal Food, Drug, and Cosmetic Act. The inspection focused on LifeCell's role as sponsor of the "PriSm" clinical study for the Strattice Fascial Inlay, a significant risk device.

Key violations include: 1. **Failure to obtain IDE approval for the "PriSm" study:** LifeCell allowed approximately (b)(4) subjects to be implanted with the Strattice device for parastomal hernia prevention, a use outside its FDA-cleared indications (K070560, K071986, K080353), without an approved IDE application. 2. **Failure to obtain IDE approval for "Two-Stage Breast Reconstruction" study:** LifeCell permitted (b)(4) subjects to receive the Strattice device for breast reconstruction, using it as a "replacement" rather than "reinforcement" (K082176), without IDE approval. 3. **Failure to obtain IDE approval for "Repair of Infected or Contaminated Hernias (RICH)" study:** LifeCell implanted the Strattice device in (b)(4) subjects for infected hernia repair, a use not cleared