FDA WARNING_LETTER - Encompass Group, LLC - August 10, 2011

On August 8-10, 2011, an FDA inspection of Albahealth, LLC, a subsidiary of Encompass Group, LLC, revealed that their PulSTAR Anti-Embolism Wrap System devices were adulterated and misbranded.

The devices were adulterated because manufacturing, packing, storage, or installation methods did not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR 803). Specific violations included: 1. Failure to establish and maintain adequate procedures for validating device design and risk analysis (21 CFR 820.30(g)). The firm lacked documentation of design validation before production and marketing, and evidence of risk analysis during design activities. 2. Failure to establish and maintain adequate procedures for the identification, documentation, validation, or verification, review, and approval of design changes before implementation (21 CFR 820.30(i)). A material change in February 2010 was implemented without updating specifications or documenting material strength testing, leading to product tearing and removal. 3. Failure to establish and maintain adequate procedures to ensure design requirements are appropriate for intended use, including user and patient needs (21 CFR 820.30(c)). Design input requirements for the PulSTAR System were not provided or adequately documented.

The devices were misbranded due to: 1. Failure to develop,