# FDA 483 - Paket Corp - August 06, 2019

Source: https://www.keypedia.com/records/483/paket-corp/06616500-055a-4d8c-a6f7-8b3c9237e67e

> FDA 483 for Paket Corp on August 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Paket Corp
- Inspection Date: 2019-08-06
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Paket Corp, a drug manufacturer and repacker in Chicago, IL, revealed significant deficiencies in their quality control unit and overall adherence to cGMP. The firm lacked numerous essential written procedures for critical operations such as annual product reviews, QA release, master batch records, process validation, OOS investigations, and change management. Additionally, issues were noted with cleaning procedures, documentation of production activities, and the product recall system.

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## Related Officers

- [Brian D. Nicholson](https://www.keypedia.com/people/brian-d-nicholson/83ea13dd-6753-468a-a0ca-19e3ef4158dd)

Company: https://www.keypedia.com/companies/paket-corp/d481ddcc-529a-4378-96ef-b3a4eef1f44b

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669