483
Safeguard US Operating LLCFDA 483 - Safeguard US Operating LLC - March 25, 2022
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Safeguard US Operating LLC, a medical device manufacturer in Harrisburg, NC, received a Form FDA 483 citing significant quality system deficiencies. Observations included inadequate documentation of corrective and preventive actions, failure to properly investigate device complaints, and a lack of procedures for reworking nonconforming products. Additionally, the firm was cited for illegible labeling on its medical devices.
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