> ## 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.

# Multiple Violations in Foshan Miwei Cosmetics Inspection
- URL: https://www.fdaweb.com/multiple-violations-in-foshan-miwei-cosmetics-inspection/
- Published: 2026-04-28T12:00:00.000Z
- Updated: 2026-09-14T13:38:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161051

A 10/20-10/24/2025 FDA inspection at the Foshan Miwei Cosmetics Co. drug manufacturing facility in Foshan, China, found current good manufacturing practice (CGMP) violations in the firm’s production of misbranded unapproved new drugs. A 4/20 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/foshan-miwei-cosmetics-co-ltd-722272-04202026?ref=fdaweb.com) says the specific violations were:,

- failure to have for each batch of drug product an 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 conduct for each batch of drug product appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms;
- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality; failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals; and failure to conduct microbiological testing before using each lot of a component with potential for objectionable microbiological contamination in light of its intended use;
- failure to establish and follow a 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; and
- failure to establish written responsibilities and procedures applicable to the quality control unit and to follow such written procedures.

FDA recommends that Foshan engage a qualified consultant to perform a comprehensive audit of its entire operation for CGMP compliance and assist it in meeting CGMP requirements.

The letter says three of the firm’s products are legally considered to be drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease and/or because they are intended to affect the structure or any function of the body. They are unapproved new drugs, the agency says, because they do not have an FDA-approved application in effect. The letter adds that the three products do not meet the requirements to be over-the-counter monograph drugs.

FDA further found that the products are misbranded because their labeling is false or misleading for several reasons. They are also misbranded, it says, because their labeling does not contain adequate directions for use.

The agency placed all of the firm’s products on a 2/13 Import Alert.

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