A Beckman Coulter facility in Brea, Calif., has been issued an FDA warning letter for failing to follow required procedures in making design changes of its photometer boards, according to the warning letter.
FDA inspectors found the company's verification study for the conformal coating for pre-amp photometer boards was conducted after its validation study was completed, and the company was unable to provide documentation of the production of the re-designed photometer boards used in validation studies.
Records also failed to establish the company's conformal coating application method and the minimal thickness required on the board.
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