Importantly, an FDA investigator's list of inspection observations does not constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations.
In accordance with normal practice, Philips Respironics will submit its response to the inspectional findings for review by the FDA. On November 12, 2021, the FDA published a list of the observations it provided to Philips Respironics. Following the substantial ramp-up of its production, service, and repair capacity, the repair and replacement program in the US and several other markets is under way.Īs expected, the US Food and Drug Administration (FDA) recently conducted an inspection of a Philips Respironics manufacturing facility in connection with the recall. Amsterdam, the Netherlands – On June 14, 2021, Royal Philips’ (NYSE: PHG, AEX: PHIA) subsidiary, Philips Respironics, initiated a voluntary recall notification* for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices.
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