Siemens Medical Solutions USA, Inc. – FDA Warning Letter, Aug 7, 2007

This FDA Warning Letter (2008-NOL-07) was issued to Siemens Medical Solutions USA, Inc., Molecular Imaging Division, following an inspection from July 16, 2007, to August 7, 2007, at their Knoxville, Tennessee facility. The firm manufactures molecular imaging diagnostic equipment, which are classified as devices under the Federal Food, Drug, and Cosmetic Act. The inspection revealed these devices are adulterated because their manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

The firm's August 20, 2007, response to the FDA 483 was deemed inadequate. Key violations include:

1. **Failure to control design validation (21 CFR 820.30(g)):** Acceptance criteria were incomplete before validation, leading to an error in ECAT scanner software not tested during validation. Risk analysis was incomplete and not updated for increased probability after multiple incidents of PET/CT scans linked to incorrect patients, and no risk analysis was performed for complaints concerning incorrect normalization values. 2. **Inadequate CAPA procedures (21 CFR 820.100(a)(1)):** Procedures inadequately identify quality data for analysis or statistical methods to detect recurring problems