Overview

KVK Tech, Inc. is a privately held pharmaceutical company specializing in the development and manufacturing of generic medications. The company is committed to providing high-quality, affordable pharmaceutical products to improve patient care.

Therapeutic areas

FDA compliance signals

31 FDA enforcement records linked to this company.

  • recall — Class II2025-05-28

    cGMP deviations

  • recall — Class II2025-05-28

    cGMP deviations

  • 4832025-03-14

    Test methods

  • 4832025-03-14

    Manufacturing Instructions and Specifications

  • 4832025-03-14

    Equipment Design, Size and Location

  • 4832025-03-14

    Cleaning / Sanitizing / Maintenance

  • recall — Class I2023-10-25

    Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.

  • 4832022-07-08

    Written procedures not established/followed

  • 4832022-07-08

    Procedures not in writing, fully followed

  • 4832022-07-08

    Computer control of master formula records

  • 4832022-07-08

    Complaint Handling Procedure

  • 4832022-07-08

    Documentation of Sampling Performed

  • 4832022-07-08

    Instruments, apparatus, et. al. not meeting specs

  • 4832022-07-08

    Rejected in-process materials not quarantined

  • 4832022-07-08

    Buildings not maintained in good state of repair

Ready to Accelerate Your
Discovery Workflow?

Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 14 days.