An FDA inspection at Siemens Healthcare Diagnostics, Tarrytown, NY, last October through December found Quality System Regulation violations in the firm’s production of the AD VIA Centaur iPTH immunoassay. A May 29 Warning Letter from FDA’s New York District Office said the agency also determined that the company did not obtain approval for the assay.
Specific violations noted included:
- Failure to establish and maintain adequate procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient.
- Failure to establish and maintain adequate procedures to ensure that formal documented reviews of design results are planned and conducted at appropriate stages of the device’s design development.
- Failure to establish and maintain adequate procedures for the identification, documentation, validation, review, and approval of design changes before their implementation.
- Failure to establish and maintain adequate plans that describe or reference the design and development activities and define responsibility for implementation.
- Failure to establish and maintain adequate procedures for verifying the device design; and
- Failure to adequately review and evaluate all complaints to determine whether an investigation is necessary.
The letter said the inspection also determined that the firm did not have an approved PMA or IDE in place for the assay and did not notify FDA of its plans to introduce the device into commercial distribution. Siemens was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of those steps, and a timetable for completion.
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