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# CGMP Violations at kdc/one Chatsworth
- URL: https://www.fdaweb.com/cgmp-violations-at-kdc-one-chatsworth-d5161814/
- Published: 2026-09-22T16:00:00.000Z
- Updated: 2026-09-22T16:00:00.000Z
- Author: David McFarland
- Tags: Drugs, Legacy-ID-D5161814, #Import 2026-09-24 19:50

A 3/31-4/3 FDA inspection at the kdc/one Chatsworth drug manufacturing facility in Chatsworth, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 9/8 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kdcone-chatsworth-inc-733205-09082026?ref=fdaweb.com) says the violations were:

- failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release, and failure to establish and follow an adequate written stability testing program including reliable, meaningful, and specific test methods for assessing the stability characteristics of the drug products;
- failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
- failure to store drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity are not affected,

FDA recommends that the company engage a qualified consultant to assist it in meeting CGMP requirements. It also says the firm’s inspection history indicates that its quality unit is not able to fully exercise its authority and/or responsibilities.

kdc/one was told to address the violations promptly and to ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence.