German Firm Cited for Procedural, Quality Control Shortcomings

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.

In addition, a review of batch records revealed the facility lacked real-time verification for critical manufacturing steps. Each batch component was not added by one person and verified by another.

Equipment cleaning and maintenance procedures to protect sanitary equipment from contamination were found to be deficient. Specifically, one of the firm’s cleaning validation reports did not cover swab samples, only evaluating rinse samples during cleaning validation.

The agency also flagged GMP training deficiencies, saying GMP training was not conducted continually and frequently at the facility to ensure that quality control employees in charge of testing products and raw materials were aware of current GMP requirements.

The firm also had inadequate written procedures for annual evaluations and handling recall reviews. It failed to include a procedure for conducting a mock recall check and did not perform the check for U.S. over-the-counter marketed drug products. Laboratory controls also did not include appropriate test procedures to ensure product conformity for standards of identity, strength, purity and quality.