KVK Tech, Inc.
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.
Core services & business areas
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
Cleaning / Sanitizing / Maintenance
- 4832025-03-14
Equipment Design, Size and Location
- 4832025-03-14
Manufacturing Instructions and Specifications
- 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
Documentation of Sampling Performed
- 4832022-07-08
Investigations of discrepancies, failures
- 4832022-07-08
Buildings of Suitable Size, Construction, Location
- 4832022-07-08
Computer control of master formula records
- 4832022-07-08
Buildings not maintained in good state of repair
- 4832022-07-08
Complaint Handling Procedure
- 4832022-07-08
Rejected in-process materials not quarantined
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