# FDA 483 - KVK Tech, Inc. - March 14, 2025

Source: https://www.keypedia.com/records/483/kvk-tech-inc/8d1befc6-0bed-4904-beeb-c20702373802

> FDA 483 for KVK Tech, Inc. on March 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KVK Tech, Inc.
- Inspection Date: 2025-03-14
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: KVK Tech, Inc. in Newtown, PA, a human drug manufacturer, was cited for significant deficiencies during an FDA inspection from March 3-14, 2025. The inspection revealed repeat observations regarding inadequate cleaning and maintenance of drug manufacturing equipment, including widespread API cross-contamination in "cleaned" areas and equipment. Additional issues included poorly designed equipment for cleaning, unvalidated test methods for cleaning verification, and discrepancies between master batch records and process validation studies.

## 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 - 2022-07-08](https://www.keypedia.com/records/483/kvk-tech-inc/da0d7f66-72b8-496b-b461-c0c35a58f30c)

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)
- [Drug Investigator](https://www.keypedia.com/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)
- [issuing_officer](https://www.keypedia.com/people/michael-o-idowu/795647ab-8f6b-47cc-ae88-3b2c61192861)
- [Michael G Ydowy](https://www.keypedia.com/people/michael-g-ydowy/cb8d0518-16a4-4633-99db-ed196a6a7429)

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