# FDA 483 - KVK Tech, Inc. - July 08, 2022

Source: https://www.keypedia.com/records/483/kvk-tech-inc/da0d7f66-72b8-496b-b461-c0c35a58f30c

> FDA 483 for KVK Tech, Inc. on July 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KVK Tech, Inc.
- Inspection Date: 2022-07-08
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: KVK-Tech, Inc. received a Form 483 citing significant deficiencies across its manufacturing and quality control operations. Key issues include inadequate facility maintenance leading to repeated water leaks in GMP areas, incomplete cleaning validation for shared equipment, and unsuitable construction of a dispensing room. The firm also failed to thoroughly investigate discrepancies, properly manage consumer complaints, maintain adequate batch records, reconcile rejected materials, and ensure data integrity for laboratory systems.

## Related Documents

- [483 - 2019-04-16](https://www.keypedia.com/records/483/kvk-tech-inc/dfcd2b3d-692b-42f9-ab71-b7583df7e57b)
- [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 - 2025-03-14](https://www.keypedia.com/records/483/kvk-tech-inc/8d1befc6-0bed-4904-beeb-c20702373802)

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)
- [investigator](https://www.keypedia.com/people/monika-borkowska/4dedee7d-7b93-4f1b-be3b-17ab41e5c0ff)

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