FDA Detects Deviations from CGMP at Denmark’s ALK-Abello

Jul 22, 2016
By BioPharm International Editors

Allergy immunotherapy manufacturer ALK-Abello recently received an inspection letter from FDA, in which the agency cited deviations in the company’s CGMP practices and “significant objectionable conditions” at its Horsholm, Denmark location.

According to FDA, the facility did not take the proper measures to control microbiological contamination. Some of the specific violations include the improper testing of water-for-injection use points for endotoxin in the aseptic manufacture of its product Pharmalgen (lyophilized allergenic venom extracts for insect stings), use of expired agar plates for environmental monitoring, and lack of growth promotion studies on the media used in products (a repeat observation from an inspection in 2014). There were no procedures in place for bioburden excursions, and there were 80 documented excursions of this type since FDA’s 2014 inspection. FDA says that preventive actions to limit microbial load excursions were not implemented until January 2016.

The company was also cited with not following through with quality assurance procedures for its equipment—a leaking lyophilizer that had temperature failures and a malfunctioning filling machine were the causes of numerous bad batches of product.

Lastly, FDA says ALK-Abello has no written procedures for how the stability of their products is tested, nor documentation surrounding the sampling and testing of its Pharmalgen, grass, and ragweed drug product and drug substance samples. It estimates that 125 of these types of products were not tested for stability since 2014.

Source: FDA

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