# FDA 483 - Safeguard US Operating LLC - March 25, 2022

Source: https://www.keypedia.com/records/483/safeguard-us-operating-llc/c4b06921-2e21-4ee2-a8af-e16aa2486807

> FDA 483 for Safeguard US Operating LLC on March 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safeguard US Operating LLC
- Inspection Date: 2022-03-25
- Product Type: device
- Office Name: Atlanta District Office
- Summary: 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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Company: https://www.keypedia.com/companies/safeguard-us-operating-llc/b351a7f7-18a7-4c3e-b711-ec3c5035b38d

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7