# FDA 483 - Avery Biomedical Devices, Inc. - July 16, 2019

Source: https://www.globalkeysolutions.net/records/483/avery-biomedical-devices-inc/630b21c7-014c-4a81-b4f3-8d111465b54f

> FDA 483 for Avery Biomedical Devices, Inc. on July 16, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avery Biomedical Devices, Inc.
- Inspection Date: 2019-07-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Avery Biomedical Devices, Inc., a medical device manufacturer in Commack, NY, was inspected by the FDA from July 11-16, 2019. The inspection revealed a significant issue regarding equipment calibration documentation. Specifically, a generator used for in-house calibration of other devices was not calibrated and lacked traceability to the National Institute of Standards and Technology (NIST).

## Related Documents

- [483 - 2017-04-17](https://www.globalkeysolutions.net/records/483/avery-biomedical-devices-inc/2d5194de-4889-48d0-ab21-7fa0fd9500da)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/avery-biomedical-devices-inc/d8b8209f-40b0-48d3-94a0-30333f988c0d

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