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Diagnostics firm Clinical Diagnostic Solutions (CDS) was recently warned by the FDA for failing to comply with current good manufacturing practices at its Plantation, Fla., plant.
The FDA recently warned devicemaker Evermed for manufacturing hospital beds using methods that don't conform with current good manufacturing practices (cGMP).
In light of the time and money required to conduct good manufacturing practice (GMP) training sessions, it is crucial that employers take every step possible to ensure training efforts are retained and carried into the workplace, according to training expert David Markovitz, founder and president of the Institute for Effective Innovation.
Drugmakers looking to achieve quality system goals may want to set their sights on configuration management technologies, which are gaining increased acceptance among life science companies.
A manufacturer of Rx cough/cold combination products has been cited by the FDA for multiple current good manufacturing practice (cGMP) violations at its Somerset, N.J., facility.
The FDA has accused a California devicemaker of widespread violations of good manufacturing practices (GMP) and quality system (QS) regulations at its Huntington Beach facility.
Failing to comply with FDA GMPs can have serious financial ramifications for a pharmaceutical firm — a reality that needs to be reflected in the priorities and actions of drug manufacturers’ boardrooms, according to a compliance and quality management expert.
Acting FDA Commissioner Lester Crawford announced late last month that the agency won’t release its multicenter analysis of cGMPs until August, roughly two months later than previously planned.
Failing to comply with FDA good manufacturing practices (GMPs) can lead to losses of money and time as surely as straying outside the legal boundaries regarding fiscal responsibility can — a reality that needs to be reflected in the priorities of manufacturers' boardrooms, according to a compliance and quality management expert.