# FDA 483 - Pharmaceutical Innovations, Inc. - June 19, 2017

Source: https://www.keypedia.com/records/483/pharmaceutical-innovations-inc/355ac9f8-987a-4280-a222-b6d19708c857

> FDA 483 for Pharmaceutical Innovations, Inc. on June 19, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutical Innovations, Inc.
- Inspection Date: 2017-06-19
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Pharmaceutical Innovations, Inc. in Newark, NJ, was inspected by the FDA from May 15 to June 19, 2017, revealing significant quality system deficiencies. The firm lacked established procedures for corrective and preventive actions, design control, process validation, and acceptance activities. These issues indicate a systemic failure to ensure product quality and compliance with regulatory requirements for medical device manufacturing.

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Company: https://www.keypedia.com/companies/pharmaceutical-innovations-inc/69609a9c-e8c3-4333-904d-0f490448d008

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