# FDA 483 - KVK-TECH, INC. - March 13, 2020

Source: https://www.keypedia.com/records/483/kvk-tech-inc/f6962d54-9403-47c9-9e1e-546e27b757a1

> FDA 483 for KVK-TECH, INC. on March 13, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KVK-TECH, INC.
- Inspection Date: 2020-03-13
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of KVK-Tech, Inc. in Newtown, PA, revealed significant deficiencies across multiple systems, including facility and equipment, packaging and labeling, laboratory controls, and quality systems. The firm failed to follow written procedures for equipment cleaning, maintain chronological logs, control access to limited areas, and adequately review electronic audit trails. Additionally, issues were noted with facility sanitation, incomplete batch records, deficient cleaning and sanitization schedules, and inadequate laboratory control mechanisms and analytical test procedures. The quality unit also failed to ensure proper change control, conduct internal audits, and qualify consultants, indicating systemic failures in GMP compliance.

## Related Officers

- [Michele Gottshall](https://www.keypedia.com/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)
- [Investigator](https://www.keypedia.com/people/nancy-m-espinal/f4494790-6a37-4998-853c-f859a0eb3330)

Company: https://www.keypedia.com/companies/kvk-tech-inc/aa6644c3-546f-42ce-b5f0-e2e926f2a349

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