# FDA 483 - Appco Pharma LLC - August 19, 2022

Source: https://www.globalkeysolutions.net/records/483/appco-pharma-llc/383ce386-ac41-4477-8ec2-01baa182d21d

> FDA 483 for Appco Pharma LLC on August 19, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Appco Pharma LLC
- Inspection Date: 2022-08-19
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Appco Pharma LLC, a drug manufacturer in Piscataway, NJ, was cited for multiple deficiencies related to environmental control, quality unit oversight, and inventory management. The inspection revealed significant issues with monitoring and documenting temperature and humidity conditions for stability samples, manufacturing areas, and storage locations. Additionally, cleaning procedures for equipment were inadequate, and the quality unit failed to ensure proper oversight and investigation of environmental excursions.

## 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 - 2023-08-29](https://www.globalkeysolutions.net/records/483/appco-pharma-llc/59a273fd-4c91-444e-9ad5-c199131868cc)
- [483 - 2024-03-11](https://www.globalkeysolutions.net/records/483/appco-pharma-llc/1b46e495-7d63-4606-8eea-c099ef180959)

## Related Officers

- [Tanya R. Syffrard](https://www.globalkeysolutions.net/people/tanya-r-syffrard/a78a42b3-6cef-46d9-9698-ec6082956477)
- [Investigator](https://www.globalkeysolutions.net/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)
- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

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