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Companies that manufacture single-entity or co-packaged combination products must adhere to manufacturing regulations governing both pharmaceutical products and medical devices, according to a draft guidance released Sept. 29 as part of the FDA’s pharmaceutical current good manufacturing practice (cGMP) initiative.
The FDA this fall will start using a risk-based approach for prioritizing site inspections for certain pharmaceutical products, the agency announced yesterday in a final report on its current good manufacturing practice (cGMP) initiative.
The FDA cited a Michigan cardiovascular device firm last week for failing to observe the quality system (QS) regulation and current good manufacturing practices (cGMPs).
The FDA issued a warning letter to French vaccine maker Aventis Pasteur following a March inspection of the company’s Lyon, France, manufacturing facility that revealed capping defects in numerous lots of Thymoglobulin, which is indicated for the prevention and treatment of kidney transplant rejection.
The FDA recently issued a warning letter to Ohio-based drug manufacturer Gentere for allegedly compounding nonsanctioned copies of commercially available drugs.
The FDA issued a warning letter July 22 to New York-based contract packaging firm Ultra-Seal for violating numerous cGMP standards, including inaccurate labeling on several lots of ephedrine tablets.
Acting FDA Commissioner Lester Crawford confirmed last week that the unveiling of the agency’s highly anticipated overhaul of pharmaceutical GMPs would occur within the next several months.
The FDA plans to implement a series of recommendations during the next half year on best management practices relating to the agency’s drug review process.
The FDA has warned a British Columbia device firm for failing to maintain adequate procedures under the quality system (QS) regulation or current good manufacturing practice (cGMP) requirements.