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Medical device firm AMF Support Services received an FDA warning letter in November citing numerous failures on the part of the firm to acquire “premarket approval or a determination of substantial evidence” for its Cool Heat Versatility Heating Mattress System.
The FDA issued a warning letter to Alabama-based devicemaker Wilson Instruments for Medicine last month after inspectors determined that the firm failed to implement numerous quality control procedures.
The FDA is suppressing documents requested by Congress that address whether the flu vaccine shortage could have been prevented, the top Democrat on the House Government Reform Committee has charged.
Limiting the exposure of sterile product elements, maintaining the highest degree of environmental control, optimizing process flow and designing equipment to prevent entrainment of lower quality air in clean rooms is essential for preventing contamination in the sterile drug manufacturing process, according to an FDA final guidance.
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must adhere to manufacturing regulations governing both pharmaceutical products and medical devices, according to a draft guidance released Sept. 29 as part of the FDA’s pharmaceutical cGMP initiative.
Pharmaceutical firms need to start building quality into their products and eschew the idea that testing alone can be relied upon to ensure product quality -- that's the overarching philosophy of the FDA's draft guidance on implementing a quality systems approach to drug manufacturing.
The FDA last week released its long-awaited final report on the pharmaceutical current good manufacturing practice (cGMP) initiative and while the information package is aimed primarily at drugmakers, it did contain two draft guidances -- one on combination products and another on computerized systems used in clinical trials -- that have a direct bearing on devicemakers.
The FDA will start using a risk-based approach for prioritizing site inspections for certain pharmaceutical products, the agency announced in a final report on its current good manufacturing practice (cGMP) initiative.
Limiting the exposure of sterile product elements, maintaining the highest degree of environmental control, optimizing process flow and designing equipment to prevent entrainment of lower quality air in clean rooms is essential for preventing contamination in the sterile drug manufacturing process, according to an FDA final guidance.