Warning Letter - No Testing for EC/DEG and other Deficiencies

The FDA inspected the premises of Multaler et Cie SAS from April 15 to 17, 2024 and observed several violations of the requirements of Good Manufacturing Practice (CGMP). In addition, the product YONKA PARIS SOLAR CARE SPF 50 UVA/UVB BROAD SPECTRUM FACE SUNSCREEN was found to have been introduced into the US market as an unauthorized and misbranded drug product.

Main violations:

1. Testing of components:

• No identity testing was performed for critical ingredients such as glycerin and propylene glycol, which pose a high risk of contamination (e.g. diethylene glycol, DEG, or ethylene glycol, EG).
• Instead, reliance was placed on certificates of analysis (COAs) from suppliers without regularly checking their credibility.

2. Laboratory controls:

• Chemical and microbiological test methods had not been validated.
• Testing was performed without positive or negative controls and did not meet the requirements of the United States Pharmacopeia (USP).
• Not all microbiological risks (e.g. Burkholderia cepacia) were tested for.

3. Water system:

The water system used was poorly designed (e.g., dead legs) and not properly maintained, which increased the risk of microbial contamination.

4. Unauthorized and misbranded medicinal product:

Based on the statements in the product description, the product would be intended for the diagnosis, cure, alleviation, treatment, or prevention of disease, and/or is intended to affect the structure or a function of the body. This would define it as a drug product under 21 CFR 201.128.

5. Noncompliance with the OTC monographs:

The YONKA PARIS SPF 50 sunscreen product contains an unauthorized combination of active ingredients (octocrylene, oxybenzone, avobenzone, ensulizole) and does not meet the OTC monograph requirements. It has not been recognized as safe and effective (GRASE), nor does it have FDA marketing authorization.

6. Cosmetic manufacturing:

Some cosmetic products may have been manufactured under unsanitary conditions, which may lead to adulteration under the FD&C Act. The company may also fall under the requirements of the Modernization of Cosmetic Regulations Act (MoCRA) of 2022.

FDA requests:

• Conduct DEG and EC testing for all high-risk ingredients and risk analysis for products already shipped.
• Review and validation of testing methods and implementation of a robust monitoring system for suppliers.
• Improve the water system and ensure compliance with USP specifications.
• Measures to trace and potentially recall affected products and improve production standards.

The FDA requires detailed reports and action plans within 30 days to address the identified deficiencies and ensure the safety of products on the US market.

Further details are provided directly in the FDA's Warning Letter.