FDA WARNING_LETTER - Eagle Health Supplies, Inc. - July 26, 2010

On November 24, 2010, the FDA issued a Warning Letter to Eagle Health Supplies, Inc. following an inspection from July 14-26, 2010. The firm, a specification developer, initial importer, and distributor of disposable 4-O2 CPR Mouth Barriers, was found to have adulterated devices under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. Failure to establish and maintain Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a)). 2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)). 3. Failure to establish and maintain procedures to ensure purchased products and services conform to requirements, including supplier evaluation and control (21 CFR 820.50). 4. Failure to establish and maintain procedures for acceptance activities, including documented receiving and finished device acceptance (21 CFR 820.80(a)). 5. Failure to establish and maintain procedures for design change control (21 CFR 820.30(i)). 6. Failure to maintain Device Master Records