FDA Issues Warning Letter to Aqualex Over Sunscreen GMPs

The US Food and Drug Administration (FDA) issued a warning letter to Aqualex Co. Ltd., South Korea. According to FDA, Aqualex violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. FDA maintains the company’s methods, facilities or controls for manufacturing, processing, packing or holding do not conform to CGMP. As a result, the product is adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Furthermore, FDA noted that “DBH Beverly Hills, EGF FGF DNA, UV Shield” is an unapproved new drug introduced or delivered for introduction into interstate commerce and is misbranded under sections of the FD&C Act.

Aqualex is a contract manufacturer of over-the-counter (OTC) sunscreens. According to FDA, the company failed to provide data to demonstrate that it adequately validated manufacturing processes used to manufacture OTC drug products and failed to demonstrate that its processes are reproducible and controlled to consistently yield drugs of uniform character and quality. Specifically, Aqualex failed to provide evidence for the qualification of manufacturing equipment.

In its initial response, Aqualex said it plans to perform several corrective action and preventive action (CAPA) including establishing a procedure for qualifying manufacturing equipment. However, FDA said Aqualex’s response is inadequate as it did not assess the impact of unqualified equipment on the quality of drug products manufactured and commercially distributed in the US. Further, Aqualex did not provide a detailed plan or supporting evidence (e.g., procedures and protocols) for validating equipment or manufacturing processes.

More Violations Uncovered

According to FDA, Aqualex failed to use equipment in the manufacture, processing, packing or holding of drug products that is of appropriate design, adequate size and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. FDA said Aqualex failed to adequately design its water system to ensure that it was suitable for producing water used in drug product formulation.

FDA also noted the Aqualex quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality and purity. In another violation, FDA said Aqualex failed to perform adequate release testing for each batch of the drug product prior to distribution. For example, FDA charged Aqualex released multiple batches of its OTC SPF sunscreen drug product to the US market without performing growth promotion testing on the media used for finished product. Further, Aqualex failed to perform growth promotion testing on the media used for water and failed to validate the test method for the determination of total microbial count in water samples, according to FDA.