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# CGMP Violations at Zhejiang Easyclean
- URL: https://www.fdaweb.com/cgmp-violations-at-zhejiang-easyclean/
- Published: 2025-06-03T12:00:00.000Z
- Updated: 2026-09-14T15:13:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159290

An FDA review of records submitted by Zhejiang Easyclean Daily Chemical Co., Ltd. in Hangzhou, China, in response to a 3/11/2024 agency request, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 5/14 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhejiang-easyclean-daily-chemical-co-ltd-702295-05142025?ref=fdaweb.com) says the specific 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;
- failure to establish an adequate written testing program designed to assess the stability characteristics of drug products and to use stability testing results to determine appropriate storage conditions and expiration dates;
- failure to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced; and
- 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.

The agency recommends that the company engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Zhejiang Easyclean was told to promptly correct the violations and to respond with a list of the specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.