# FDA 483 - PQ Corporation - February 22, 2022

Source: https://www.globalkeysolutions.net/records/483/pq-corporation/b4a92c6a-fccb-4029-b49b-5d29746a0dd9

> FDA 483 for PQ Corporation on February 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PQ Corporation
- Inspection Date: 2022-02-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: PQ Corporation, a drug substance manufacturer in Utica, IL, received an FDA Form 483 with six observations. The inspection revealed significant deficiencies including a lack of an independent quality unit, untimely investigations, inadequate documentation for lot control, poor facility maintenance, and unvalidated computerized systems. These issues indicate a need for comprehensive improvements in the firm's quality assurance and control processes.

## Related Officers

- [Norman K. Starks](https://www.globalkeysolutions.net/people/norman-k-starks/4b8776e0-f96e-429c-94d1-40c0369f5378)
- [Nibin Varghese](https://www.globalkeysolutions.net/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)

Company: https://www.globalkeysolutions.net/companies/pq-corporation/a1c020b7-ebbf-4601-9fdf-72421089b849

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-vi/4a1cadca-f04c-44d0-8d7a-4e1d6e583766