# FDA 483 - LaunchPOrt Llc - July 24, 2019

Source: https://www.globalkeysolutions.net/records/483/launchport-llc/a6e36b69-e29a-4bd4-965f-d8a31aac3e89

> FDA 483 for LaunchPOrt Llc on July 24, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: LaunchPOrt Llc
- Inspection Date: 2019-07-24
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Engineered Medical Systems Baltimore, a medical device contract manufacturer, revealed two significant observations. The firm failed to validate a manufacturing process whose results cannot be fully verified by subsequent inspection and test. Additionally, software used as part of production and the quality system had not been validated for its intended use.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/launchport-llc/1ecb7f81-ba2d-49a8-a162-624c8519f0c9

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