# FDA 483 - Appco Pharma LLC - November 06, 2018

Source: https://www.globalkeysolutions.net/records/483/appco-pharma-llc/77127765-6933-4bf8-8395-40e6347a7f9b

> FDA 483 for Appco Pharma LLC on November 06, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Appco Pharma LLC
- Inspection Date: 2018-11-06
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Appco Pharmaceuticals LLC in Piscataway, NJ, was inspected from October 25 to November 6, 2018, revealing significant deficiencies in their facilities and equipment systems. The inspection cited issues with the appropriate design, location, and calibration of analytical balances and a check-weigher machine. These findings indicate a lack of adequate control over critical manufacturing equipment, which could impact product quality and data integrity.

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## Related Officers

- [Director, Enterprise Regulatory Compliance](https://www.globalkeysolutions.net/people/nicholas-a-violand/c0c3ee7a-8adb-43d2-974c-06220ef8e8eb)
- [James R. Birkenstamm](https://www.globalkeysolutions.net/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)

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