Warning Letter — kdc/one Chatsworth, Inc.
The FDA issued a Warning Letter to kdc/one Chatsworth, Inc. following an inspection by the Center for Drug Evaluation and Research (CDER). The letter identifies specific violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
This notice affects kdc/one Chatsworth, Inc., as well as its manufacturing, quality, and regulatory personnel responsible for drug production and compliance oversight.
The issuance of a Warning Letter by CDER indicates that the FDA identified significant deviations from CGMP requirements. This action suggests that existing quality systems at the facility may have been insufficient to ensure the safety and efficacy of manufactured drug products, potentially leading to increased regulatory scrutiny or restrictions on product distribution until compliance is achieved.
Quality and manufacturing teams should verify that all facility-specific drug manufacturing processes are in strict compliance with CGMP regulations. Contract manufacturing sites should review recent inspectional observations to ensure prompt remediation of any noted deficiencies.
FDA Warning Letter issued to: kdc/one Chatsworth, Inc.. 09/08/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kdcone-chatsworth-inc-733205-09082026
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