# FDA 483 - Angel Medical Systems, Inc. - March 28, 2022

Source: https://www.keypedia.com/records/483/angel-medical-systems-inc/12e7063e-f102-4acc-94ff-4a7db7f3d04a

> FDA 483 for Angel Medical Systems, Inc. on March 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Angel Medical Systems, Inc.
- Inspection Date: 2022-03-28
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Angel Medical Systems, Inc., a medical device manufacturer in Eatontown, NJ, was cited for several quality system deficiencies during an FDA inspection. The observations highlight inadequate procedures for corrective and preventive actions, lack of process controls for reprocessed devices, insufficient design verification documentation, and issues with supplier management. These findings indicate a need for the firm to improve its adherence to quality system regulations.

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## Related Officers

- [Frank J. Marciniak](https://www.keypedia.com/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)

Company: https://www.keypedia.com/companies/angel-medical-systems-inc/c56bcc58-adf6-4768-9426-63ca1015791f

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248