# FDA 483 - InvaTech Pharma Solutions, LLC - June 09, 2023

Source: https://www.globalkeysolutions.net/records/483/invatech-pharma-solutions-llc/72351d09-9e17-4f73-a196-2f7193d5627c

> FDA 483 for InvaTech Pharma Solutions, LLC on June 09, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: InvaTech Pharma Solutions, LLC
- Inspection Date: 2023-06-09
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: InvaTech Pharma Solutions, LLC, a contract manufacturer and repacker in East Brunswick, NJ, received eight observations during an FDA inspection from June 5-9, 2023. The firm was cited for significant deficiencies in its quality system, including inadequate investigations into out-of-specification results and customer complaints, and a lack of process validation. Additional concerns involved insufficient sampling plans, deficient equipment cleaning procedures, improper storage conditions for materials and products, and uncontrolled access to labeling materials.

## Related Documents

- [483 - 2017-04-04](https://www.globalkeysolutions.net/records/483/invatech-pharma-solutions-llc/318ba5c8-a85d-4ac6-80d8-fc7143b5e93d)
- [483 - 2017-12-28](https://www.globalkeysolutions.net/records/483/invatech-pharma-solutions-llc/e53ca456-2123-47f7-a239-c00aaed5661b)
- [483 - 2019-02-05](https://www.globalkeysolutions.net/records/483/invatech-pharma-solutions-llc/2690f600-078e-48b8-9c11-01e002f1066a)

## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)

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