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# CGMP Violations in Imperial Palace Records
- URL: https://www.fdaweb.com/cgmp-violations-in-imperial-palace-records/
- Published: 2025-02-05T12:00:00.000Z
- Updated: 2026-09-14T14:52:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158604

An FDA review of the records it requested on 3/4/2024 from Imperial Palace Commodity—Dongguan—Co., Ltd., in Dongguang, Guangdong, China, a manufacturer of over-the-counter drugs, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/27 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/imperial-palace-commodity-dongguan-co-ltd-692842-01272025?ref=fdaweb.com) says the specific violations were:

- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals;
- failure to establish adequate written procedures for production and process control designed to assure that the drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess;
- failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-practice materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failure to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA says that based on the nature of the violations found at the company, it recommends that Imperial Palace engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The agency says it placed products from the firm on a 1/23 Import Alert.

Imperial Palace was told to promptly correct any violations and to respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.