TRUERELIEFAugust 13, 2021

FDA 483 - TRUERELIEF - August 13, 2021

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Record Details

TRUERELIEF in Santa Monica, CA, was inspected by the FDA from August 11-13, 2021, and received a Form 483. The inspection revealed a significant quality system deficiency related to design controls. Specifically, the firm failed to establish design plans for its medical device development activities, as demonstrated by issues with its Design History File.

Company: TRUERELIEF
Inspection Date: August 13, 2021
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Sarah A. Hassas (investigator)

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ID · 9e66e899-6c50-4303-8e6d-d0fba5a2c636