# FDA 483 - Sunrise Medical Laboratories, Inc. - November 19, 2010

Source: https://www.keypedia.com/records/483/sunrise-medical-laboratories-inc/d5c19070-8234-4fc9-935c-d55d061a98c1

> FDA 483 for Sunrise Medical Laboratories, Inc. on November 19, 2010. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sunrise Medical Laboratories, Inc.
- Inspection Date: 2010-11-19
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Sunrise Medical Laboratories, Inc. in Hicksville, NY, revealed significant deviations in their testing processes for communicable disease agents and record-keeping. The firm failed to adhere to manufacturer's instructions for various assays, potentially compromising the accuracy of donor specimen results. Additionally, critical documentation, such as incubation parameters and personnel identification, was not maintained concurrently with testing activities.

## Related Officers

- [Investigator](https://www.keypedia.com/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.keypedia.com/companies/sunrise-medical-laboratories-inc/2fd43fa3-41b7-40cf-b54f-7bdd4f3e1b73

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