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FDA Warning Letter to Zhejiang Gaorong Cosmetic: Why Quality Control Matters for Cosmetic and OTC Manufacturers
A recent FDA Warning Letter highlights the importance of raw material verification, supplier qualification, and independent quality oversight. For companies manufacturing cosmetics and OTC products for the U.S. market, the case offers an important lesson: product quality must be supported by a reliable and documented quality management system.
1. A Recent FDA Warning Letter: What Happened?
On October 1, 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Zhejiang Gaorong Cosmetic Co., Ltd., a manufacturing facility in Zhejiang, China.
The letter followed an FDA review of records submitted by the company in response to the agency's request for manufacturing records and other information.
The FDA identified significant violations of Current Good Manufacturing Practice (CGMP) requirements for finished pharmaceuticals under 21 CFR Parts 210 and 211.
The company was registered as a manufacturer of over-the-counter (OTC) drug products. The violations identified in the letter primarily concerned its OTC drug manufacturing operations.
However, the letter also included an important statement regarding cosmetics manufactured at the same facility for distribution in the United States.
The FDA reminded the company that cosmetic products must comply with applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including requirements introduced under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
This distinction is important: the cited CGMP violations were related to OTC drugs, not findings that the company's cosmetic products themselves had violated MoCRA. Nevertheless, the case provides valuable lessons for cosmetic manufacturers regarding quality management and manufacturing controls.
2. What Did FDA Identify? Three Important Quality Control Issues
A. Inadequate Raw Material Testing and Supplier Verification
One of the major findings concerned the company's failure to adequately verify incoming raw materials.
Under 21 CFR 211.84, drug manufacturers must establish appropriate procedures for testing and approving or rejecting components before they are used in manufacturing.
The FDA found that the company had not adequately demonstrated that incoming component lots were tested for identity and relevant impurities.
The company also relied on supplier Certificates of Analysis (COAs) without sufficiently establishing the reliability of the suppliers' test results through appropriate validation and periodic verification.
A supplier-provided COA may be an important part of a quality control program, but simply receiving a document does not automatically establish that the material meets the required specifications.
Manufacturers need a structured approach to:
Verify the identity of incoming raw materials.
Establish appropriate specifications for material quality and purity.
Qualify suppliers before relying on their test results.
Verify supplier testing reliability through initial validation and periodic revalidation.
Maintain appropriate testing and approval records.
The FDA also requested a comprehensive review of the company's material management system and supplier qualification procedures.
Key lesson: Supplier qualification is not simply a purchasing activity. It is an essential part of manufacturing quality management.
B. Insufficient Quality Unit Authority and Oversight
Another significant finding involved the company's quality control unit.
Under 21 CFR 211.22, a pharmaceutical manufacturer's quality control unit must have the responsibility and authority to approve or reject components, materials, manufacturing processes, packaging, labeling, and finished drug products.
The FDA found that the company's quality unit had not effectively exercised its oversight responsibilities.
Examples included inadequate oversight of:
Batch production records.
Product stability data.
Manufacturing operations.
Quality-related decisions and documentation.
The FDA requested a comprehensive assessment and remediation plan to ensure that the quality unit had sufficient authority and resources to perform its responsibilities.
This finding illustrates an important principle: quality control cannot depend solely on production personnel or management decisions.
An effective quality unit must be able to independently review manufacturing records, investigate quality issues, and make appropriate approval or rejection decisions.
For cosmetic manufacturers, establishing clear quality responsibilities and documented review procedures is also an important part of maintaining consistent product quality and supporting applicable regulatory obligations.
C. Weak Material Management and Corrective Action Systems
The FDA also requested a broader assessment of the company's material management system.
This included reviewing whether suppliers of components, containers, and closures were properly qualified and whether incoming material controls were adequate to prevent unsuitable materials from entering production.
The agency also requested a risk assessment of affected drug products and appropriate corrective and preventive actions (CAPA).
CAPA is not simply a process for correcting an individual problem. It is intended to identify the underlying cause of a quality issue, implement corrective measures, and prevent the same problem from recurring.
An effective CAPA system should include:
Identification and documentation of the quality issue.
Investigation of the root cause.
Assessment of the potential impact on affected products.
Implementation of corrective measures.
Preventive actions to address systemic weaknesses.
Verification that the corrective actions are effective.
Without a reliable CAPA system, manufacturers may repeatedly encounter the same quality problems even after individual deficiencies have been addressed.
3. Why Should Cosmetic Manufacturers Pay Attention?
Although this particular Warning Letter focused on OTC drug CGMP violations, it also explicitly addressed cosmetics manufactured at the facility for U.S. distribution.
The FDA reminded the company that cosmetics must comply with applicable requirements under the FD&C Act and MoCRA.
This is particularly relevant for manufacturers producing both cosmetics and OTC products.
In the United States, a product's regulatory classification depends on its intended use, claims, and other relevant characteristics—not simply how it is marketed or described in another country.
For example, certain products marketed as cosmetics in other markets may be regulated as OTC drugs in the United States depending on their intended use and claims.
Manufacturers therefore need to understand which regulatory framework applies to each product.
For cosmetic manufacturers, MoCRA introduced important responsibilities, including:
Cosmetic facility registration and renewal, where applicable.
Cosmetic product listing and annual updates.
Safety substantiation for cosmetic products.
Serious adverse event reporting.
Maintenance of required records and compliance with applicable FDA requirements.
These obligations are separate from the pharmaceutical CGMP provisions cited in the Zhejiang Gaorong Warning Letter.
Nevertheless, the broader quality management lessons remain relevant to cosmetic manufacturing.
A company that cannot adequately verify its ingredients, control suppliers, maintain manufacturing records, or investigate quality problems may face significant challenges in demonstrating product safety and maintaining consistent product quality.
4. A Practical Quality Control Checklist for Cosmetic Manufacturers
For companies manufacturing cosmetics for the U.S. market, the following areas deserve particular attention.
1. Raw Material Verification
Maintain appropriate specifications and supporting documentation for incoming ingredients. Establish a process to evaluate material identity, quality, and purity based on the ingredient's characteristics and associated risks.
2. Supplier Qualification
Do not rely solely on supplier documents without evaluating their reliability. Establish procedures for supplier selection, qualification, performance monitoring, and periodic reassessment.
3. Manufacturing Process Controls
Maintain documented manufacturing procedures, batch records, and appropriate controls to support consistent product quality.
4. Product Stability and Safety Documentation
Maintain appropriate safety substantiation and supporting product data. Ensure that the information used to support product safety is relevant and scientifically adequate.
5. Quality Responsibilities
Clearly define who is responsible for reviewing raw materials, manufacturing records, finished products, deviations, and quality-related decisions.
6. Corrective and Preventive Actions (CAPA)
Establish a process for investigating complaints and quality issues, identifying root causes, and implementing effective corrective and preventive measures.
5. Quality Management Is More Than Regulatory Paperwork
The Zhejiang Gaorong case demonstrates why quality management should not be treated as a collection of documents prepared only when an FDA inspection or regulatory review occurs.
A reliable quality system must operate throughout the manufacturing process—from supplier selection and raw material verification to production, finished product review, and postmarket quality monitoring.
For companies entering the U.S. cosmetics and OTC markets, understanding the distinction between cosmetic and drug requirements is equally important.
MoCRA compliance, applicable cosmetic safety obligations, and pharmaceutical CGMP requirements each have their own scope. Manufacturers should determine which requirements apply to each product and establish appropriate controls accordingly.
Ultimately, product quality is not demonstrated by a supplier's certificate or a completed registration alone. It is demonstrated by a consistent system that verifies materials, controls manufacturing, documents decisions, and supports consumer safety.
For manufacturers seeking to build a sustainable presence in the U.S. market, quality management should begin long before the first shipment arrives.
Official Reference
FDA Warning Letter: Zhejiang Gaorong Cosmetic Co., Ltd.Issued October 1, 2026 | Posted October 20, 2026Reference No. 320-27-01
FDA: 21 CFR Parts 210 and 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
FDA: Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
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