483
Hobbs Medical, Inc.FDA 483 - Hobbs Medical, Inc. - August 27, 2021
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Record Details
Hobbs Medical, Inc. in Stafford Springs, CT, a medical device manufacturer, was cited for three observations during an FDA inspection. The firm failed to adequately maintain device history records and device master records. Additionally, production processes were not controlled to ensure devices conform to specifications, indicating deficiencies in their quality system.
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