# FDA 483 - Appco Pharma LLC - March 11, 2024

Source: https://www.globalkeysolutions.net/records/483/appco-pharma-llc/1b46e495-7d63-4606-8eea-c099ef180959

> FDA 483 for Appco Pharma LLC on March 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Appco Pharma LLC
- Inspection Date: 2024-03-11
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Appco Pharma LLC, a corporate headquarters in Piscataway, NJ, was cited for significant deficiencies in its post-marketing adverse drug experience reporting system. The firm failed to investigate approximately 304 initial 15-day Alert reports and lacked adequate written procedures for the surveillance, receipt, and evaluation of adverse drug experiences. These issues indicate a serious breakdown in their pharmacovigilance processes.

## Related Documents

- [483 - 2018-11-06](https://www.globalkeysolutions.net/records/483/appco-pharma-llc/77127765-6933-4bf8-8395-40e6347a7f9b)
- [483 - 2021-07-30](https://www.globalkeysolutions.net/records/483/appco-pharma-llc/1b2e5e98-ff75-4931-b993-325988d4ad69)
- [483 - 2022-08-19](https://www.globalkeysolutions.net/records/483/appco-pharma-llc/383ce386-ac41-4477-8ec2-01baa182d21d)
- [483 - 2023-08-29](https://www.globalkeysolutions.net/records/483/appco-pharma-llc/59a273fd-4c91-444e-9ad5-c199131868cc)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/tyanna-n-hadley/8fdebfd7-d6f3-44ab-9dcb-864ab6d55d53)

Company: https://www.globalkeysolutions.net/companies/appco-pharma-llc/b4a77ba5-0e8a-47ae-94c2-951f5a0b2100

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