# FDA 483 - E-Beam Services, Inc. - April 27, 2023

Source: https://www.globalkeysolutions.net/records/483/e-beam-services-inc/4fd67091-cdc3-4150-9a48-e1c91d6acb2c

> FDA 483 for E-Beam Services, Inc. on April 27, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: E-Beam Services, Inc.
- Inspection Date: 2023-04-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: E-Beam Services, Inc., a medical device sterilizer in Cranbury, NJ, received two observations during an FDA inspection. The findings highlight deficiencies in the firm's record-keeping practices, specifically regarding the lack of detailed descriptions for document changes and incomplete device history records that omit critical processing times for sterilization.

## Related Documents

- [483 - 2020-01-27](https://www.globalkeysolutions.net/records/483/e-beam-services-inc/2173bd9b-0398-4a36-80a8-b06ddd9a2c5e)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/e-beam-services-inc/a5566d49-c8d7-400c-a288-99375b522f80

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