# FDA 483 - LifeSignals Imaging, Inc. - March 11, 2021

Source: https://www.globalkeysolutions.net/records/483/lifesignals-imaging-inc/ad678a8d-9d73-4d0f-a3d4-6213d27fe475

> FDA 483 for LifeSignals Imaging, Inc. on March 11, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LifeSignals Imaging, Inc.
- Inspection Date: 2021-03-11
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: LifeSignals Imaging, Inc., a medical device manufacturer in New York, was inspected by the FDA and received a Form 483 with three observations. The inspection revealed deficiencies in maintaining written Medical Device Reporting procedures, inadequate record-keeping for changes to documents, and failures in properly maintaining complaint files. These issues indicate a need for improved quality system controls.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.globalkeysolutions.net/companies/lifesignals-imaging-inc/c7e6e78c-c69f-481f-a547-d601340f52a4

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961