# FDA 483 - LUBRINOVATION, Inc. - August 07, 2019

Source: https://www.keypedia.com/records/483/lubrinovation-inc/79d4017c-bea6-447f-867b-be929e7cb994

> FDA 483 for LUBRINOVATION, Inc. on August 07, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LUBRINOVATION, Inc.
- Inspection Date: 2019-08-07
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of LUBRINOVATION, Inc., a medical device manufacturer in Frederick, MD, revealed two significant quality system deficiencies. The firm failed to establish adequate procedures for purchasing controls and supplier evaluation, resulting in unapproved service providers. Additionally, software used for the electronic quality management system was not validated for its intended use.

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/lubrinovation-inc/312fa5c6-a8d0-4dbe-a177-d237207c59a6

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e