# FDA 483 - InvaTech Pharma Solutions, LLC - December 28, 2017

Source: https://www.globalkeysolutions.net/records/483/invatech-pharma-solutions-llc/e53ca456-2123-47f7-a239-c00aaed5661b

> FDA 483 for InvaTech Pharma Solutions, LLC on December 28, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InvaTech Pharma Solutions, LLC
- Inspection Date: 2017-12-28
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: InvaTech Pharma Solutions, LLC in East Brunswick, NJ, received a Form 483 with three observations related to manufacturing and quality control. The firm failed to thoroughly investigate out-of-specification results, did not establish in-process hold times for drug products, and inconsistently calculated theoretical and actual yields, leading to uninvestigated out-of-trend results. These issues indicate deficiencies in their quality system and process control.

## Related Documents

- [483 - 2017-04-04](https://www.globalkeysolutions.net/records/483/invatech-pharma-solutions-llc/318ba5c8-a85d-4ac6-80d8-fc7143b5e93d)
- [483 - 2019-02-05](https://www.globalkeysolutions.net/records/483/invatech-pharma-solutions-llc/2690f600-078e-48b8-9c11-01e002f1066a)
- [483 - 2023-06-09](https://www.globalkeysolutions.net/records/483/invatech-pharma-solutions-llc/72351d09-9e17-4f73-a196-2f7193d5627c)

## Related Officers

- [Russell J. Glapion](https://www.globalkeysolutions.net/people/russell-j-glapion/54dd6274-563a-44fe-8016-2ebd700be7a0)

Company: https://www.globalkeysolutions.net/companies/invatech-pharma-solutions-llc/a4957f07-dcf0-47ec-a41a-7effe7e4a8e3

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