Company: Tri State Incorporated
Date of Enforcement Report:2/12006
Oxygen Compressed USP, size M6, D, E, C, M, and MN cylinders, Recall # D-144-6
cGMP deviations: FDA inspection of the recalling firm found that the Auto HP computerized filling system is not validated and there is no way to verify the automated vent and vacuum purge step during the prefill cycle..
Recalling Firm: Philips Medical Systems North America Co, Bothell, WA, by letter on December 9, 2005.
Tri State Incorporated, Wauseon, OH, by visit on December 9, 2005. Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE