# FDA 483 - AMKS TIME RELEASE LAB, LLC - July 12, 2013

Source: https://www.keypedia.com/records/483/amks-time-release-lab-llc/2ba44cad-717b-46ff-b70c-a837414a3788

> FDA 483 for AMKS TIME RELEASE LAB, LLC on July 12, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AMKS TIME RELEASE LAB, LLC
- Inspection Date: 2013-07-12
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of AMZE TIME RELEASE LAB, LLC in Paterson, NJ, revealed six significant observations concerning their role as a sponsor of a clinical investigation. The firm failed to submit an Investigational New Drug (IND) application, monitor the study, or maintain adequate records for the investigational product. Additionally, issues were noted with financial disclosure collection and providing proper training to investigators.

## Related Documents

- [483 - 2013-06-17](https://www.keypedia.com/records/483/amks-time-release-lab-llc/339959b3-d463-4c55-add7-1d3f54aa1e14)
- [WARNING_LETTER - 2013-07-12](https://www.keypedia.com/records/warning_letter/amks-time-release-lab-llc/ba894059-cf4d-4059-9832-b7e9358461a0)

## Related Officers

- [Regulatory Officer](https://www.keypedia.com/people/peter-r-lenahan/c695dac2-5447-434b-801e-f95e6acf05f1)

Company: https://www.keypedia.com/companies/amks-time-release-lab-llc/8f16893f-94ce-4808-afbe-20de391272e2

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