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FDA Discovers GMP Deficiencies at Denmark Facility

August 26, 2016

A Denmark-based drugmaker landed an FDA letter for several GMP violations.

In a March inspection of Alk Abello’s Horsholm, Denmark facility, FDA investigators found that not much had changed over the past two years. Specifically, investigators once again noted that the company failed to use environmental isolates to prevent microbiological contamination.

Within that time span, the company amassed 80 action level bioburden excursions in its aseptic production facility that put its products at risk of contamination. The agency’s letter states that the company neglected to take corrective measures to address this issue until January.

Among its complaints, the agency pointed out that the company failed to regularly inspect its equipment to ensure proper performance. As an example, the agency noted that the company hadn’t re-qualified its lyophilizer since 2000, and as a result several lots were aborted.

According to the letter, the company also released about 125 drug products and substance samples without stability tests. Some of those products lacked documentation of a quality control review as well.

To address the agency’s concerns, the company indicated that it would update its written procedures and training. The agency deemed the response inadequate, asking the company to provide more detail.

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