FDA Hammers on GMP Violations in 3 Warning Letters
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 storage of products. Based on these infractions, the warning letter deemed company products made at the Adamson plant to be adulterated.
The inspection conducted in early August of 2015 yielded citations for 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.
The other companies include Concept Products’ China-based manufacturing facility and the New-York based Fallon Wellness Pharmacy.