> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CGMP Violations at KVK-Tech
- URL: https://www.fdaweb.com/cgmp-violations-at-kvk-tech/
- Published: 2020-10-27T12:00:00.000Z
- Updated: 2026-09-14T16:34:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147955

A 2/4-3/13 FDA inspection at the KVK-Tech drug manufacturing facility in Newtown, PA, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/8 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kvk-tech-inc-608236-10082020?ref=fdaweb.com) says specific violations were: 

- failing to establish and follow adequate written procedures for cleaning and maintenance of equipment; and
- failing to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.

The letter says the agency cited similar CGMP violations at other facilities in the company’s network and that one site received a 2/11 Warning Letter. “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacturing of drugs is inadequate,” FDA says.

The agency recommends that KVK engage a qualified consultant to assist it in meeting CGMP requirements if the company intends to manufacture drugs for the U.S. market. It says the consultant should perform a comprehensive audit of the company’s entire operation for CGMP compliance and should evaluate the completion and efficacy of KVK’s corrective and preventive actions before it pursues resolution of its compliance status with FDA.

The letter acknowledges the firm’s commitment to suspend manufacturing drugs at a facility and says it should clarify whether it intends to resume manufacturing any drugs at the facility in the future.

KVK was told to correct the violations promptly and to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the work.