FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

German Firm Cited for Procedural, Quality Shortcomings

Jan. 19, 2018

The FDA hit BODE Chemie with a Form 483 for failing to follow proper quality control procedures, in addition to other deficiencies at its facility in Hamburg, Germany.

In a September inspection, the agency found the company’s quality assurance department did not participate in the review and release of raw materials and products tested in the quality control laboratory. The agency also found that the firm’s raw material sampling technique was inadequate, as it limited sampling to materials from only one location.

The investigator observed that the facility lacked proper controls to ensure only authorized personnel could change master production and control records in its computer system, noting that one of the firm’s standard operating procedures did not address the review of electronic data in chromatographic data assessment and product release in the QC laboratory.

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