# FDA 483 - KVK Tech, Inc. - April 16, 2019

Source: https://www.keypedia.com/records/483/kvk-tech-inc/dfcd2b3d-692b-42f9-ab71-b7583df7e57b

> FDA 483 for KVK Tech, Inc. on April 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KVK Tech, Inc.
- Inspection Date: 2019-04-16
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of KVK Tech, Inc. in Newtown, PA, a drug product manufacturer, from April 9-16, 2019, revealed significant deficiencies across multiple quality systems. The firm failed to establish adequate written procedures for its quality control unit, thoroughly investigate product discrepancies and batch failures, and maintain proper laboratory controls and data integrity. These observations indicate a lack of adherence to Good Manufacturing Practices, raising concerns about product quality and reliability.

## Related Documents

- [WARNING_LETTER - 2019-04-16](https://www.keypedia.com/records/warning_letter/kvk-tech-inc/e52dd09d-9479-459b-9c2a-bdacc44782a5)
- [WARNING_LETTER - 2020-03-13](https://www.keypedia.com/records/warning_letter/kvk-tech-inc/02202704-f49a-4279-ad1f-595444e5198c)
- [483 - 2021-06-11](https://www.keypedia.com/records/483/kvk-tech-inc/a06035e4-1651-4455-a666-65c2f30bba53)
- [483 - 2022-07-08](https://www.keypedia.com/records/483/kvk-tech-inc/da0d7f66-72b8-496b-b461-c0c35a58f30c)
- [483 - 2025-03-14](https://www.keypedia.com/records/483/kvk-tech-inc/8d1befc6-0bed-4904-beeb-c20702373802)

## Related Officers

- [Yvesna Blaise](https://www.keypedia.com/people/yvesna-blaise/4cd6b7c2-78a7-490d-9354-52046bc7344f)
- [Patric C Kiszkaeucher](https://www.keypedia.com/people/patric-c-kiszkaeucher/5e3eed20-d2ce-456f-b04c-a5eb78065347)
- [Investigator](https://www.keypedia.com/people/michael-r-klapal/b181b5e8-4fc3-48ed-b17c-791359e7b619)
- [Director, Enterprise Regulatory Compliance](https://www.keypedia.com/people/nicholas-a-violand/c0c3ee7a-8adb-43d2-974c-06220ef8e8eb)

Company: https://www.keypedia.com/companies/kvk-tech-inc/f8ea60fc-cfc0-4769-8e62-a677abd59cb9

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8