483
Kerber USA Inc.FDA 483 - Kerber USA Inc. - November 02, 2022
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Record Details
During an FDA inspection conducted from October 31 to November 2, 2022, medical device manufacturer Kerber USA Inc., located in Amherst, NY, received a Form FDA 483 outlining significant quality system deficiencies. The inspection revealed a systemic lack of established procedures critical for ensuring product quality and safety, as required by medical device regulations.
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- New York District Office
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