# FDA 483 - Appco Pharma, LLC - April 15, 2019

Source: https://www.keypedia.com/records/483/appco-pharma-llc/0fb91feb-b975-4775-8e58-7aab32f3443e

> FDA 483 for Appco Pharma, LLC on April 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Appco Pharma, LLC
- Inspection Date: 2019-04-15
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Appco Pharma, LLC in Somerset, NJ was inspected by the FDA from April 8-15, 2019. The inspection revealed a significant issue with the timely submission of periodic adverse drug experience reports (PADERs). Specifically, the firm failed to submit sixteen quarterly PADERs within the required 30-day timeframe.

## Related Officers

- [investigator](https://www.keypedia.com/people/nina-yang/8d080437-2e05-4b75-8c53-b818d761cf1f)

Company: https://www.keypedia.com/companies/appco-pharma-llc/63262db1-9074-411f-915f-f0b3e49884b8

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