The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Focuses on Data Integrity, Risk Management in Three Warning Letters

Sept. 16, 2016
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The FDA is turning up the heat on pharmaceutical firms for a range of GMP violations, firing off warning letters to three companies over issues ranging from data integrity to risk management.

One of these companies, California-based Adamson Analytical Laboratories, was cited after an inspection turned up deviations from GMP in the firm’s methods and controls for manufacturing, along with issues surrounding its processing, packing and holding of products. Based on these flaws, the warning letter deemed company products produced there to be adulterated.

The inspection conducted in August 2015 exposed the firm’s failure to establish systems-related controls as well as laboratory controls. For example, the FDA noted that laboratory personnel shared a password for liquid chromatography tests and that there was no password required to access gas chromatography data.

Furthermore, the firm failed to establish and document appropriate specifications, standards and test procedures to ensure product quality. Investigators said the firm’s response to the inspector’s findings was inadequate because a risk assessment on lots tests was not provided.

Similarly, an inspection of Concept Products’ China-based manufacturing facility in August 2015 revealed that the firm failed to ensure each drug batch met final specification requirements.

One example cited in the warning letter was the firm’s absence of written testing programs designed to assess stability characteristics, production and process controls and sterility of equipment.

The last of the company’s cited, New-York based Fallon Wellness Pharmacy, was accused of producing drug products without valid prescriptions for individual patients and producing unsterile drug products.

For example, the firm was cited for not taking remedial action when viable air samples tested positive for fungus, investigators noted several stray pieces of equipment in the aseptic area and personnel were observed wearing non-sterile garments in aseptic environments. The complaints were based on a March inspection.

FDA strongly recommended all facilities to immediately undertake a comprehensive assessment of their operations.

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