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FDAnews Device Daily Bulletin
Axis Warning Letter Cites Lack of Written Procedures
Nov. 23, 2010
Axis Health Care received a warning letter
because it lacked a number of written procedures and didn’t have clearance or approval for one of its devices. During a three-day inspection in May of Axis’ Montgomery, Ala., facility, FDA investigators found the company didn’t have adequate written procedures for such activities as design control and corrective and preventive actions, according to the warning letter. The company also was cited for not maintaining a design history file for its Picture Archive and Communication System to demonstrate it was developed in accordance with the approved design plan.
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