# FDA 483 - E-Beam Services, Inc. - January 27, 2020

Source: https://www.globalkeysolutions.net/records/483/e-beam-services-inc/2173bd9b-0398-4a36-80a8-b06ddd9a2c5e

> FDA 483 for E-Beam Services, Inc. on January 27, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: E-Beam Services, Inc.
- Inspection Date: 2020-01-27
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of E-Beam Services, Inc. in Cranbury, NJ, a sterilizer facility, revealed significant deficiencies in equipment maintenance documentation and adherence to calibration procedures. The firm failed to log repairs and associated activities for non-conformances related to their E-Beam sterilizer and did not follow established procedures for line speed calibration, without documenting any rationale for the deviation. These findings indicate a lack of control over critical equipment processes.

## Related Documents

- [483 - 2023-04-27](https://www.globalkeysolutions.net/records/483/e-beam-services-inc/4fd67091-cdc3-4150-9a48-e1c91d6acb2c)

## Related Officers

- [William R. Chang](https://www.globalkeysolutions.net/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)
- [Esteban Beltran](https://www.globalkeysolutions.net/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

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

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