FDA WARNING_LETTER - Peter Schiff Enterprises - April 12, 2013

On March 22 to April 12, 2013, the FDA inspected Peter Schiff Enterprises in Cookeville, Tennessee, which manufactures AC fibrillators (unclassified devices) and silicone-based electrode pads (Class 2 devices). The inspection revealed violations of the Quality System regulation (21 CFR Part 820), rendering the devices adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act. An FDA 483 was issued on April 12, 2013.

Key violations include: 1. Failure to establish finished device acceptance procedures (21 CFR 820.80(d)), evidenced by a product batch shipped before production records were audited and signed. 2. Failure to establish Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a)), a repeat violation from 2010 and 2011 inspections. 3. Failure to perform quality audits (21 CFR 820.22), a recurring violation since 1998. 4. Failure to adequately establish document control procedures (21 CFR 820.40), noted in 2011, with no evidence of document review/approval or current status. 5. Failure to establish management review procedures (21 CFR 82