FDA issues a warning letter and criticizes Water System at Korean Sunscreen Manufacturer

During an inspection of a Korean manufacturer producing OTC sunscreen, Aqualex Co., Ltd., the FDA identified multiple Good Manufacturing Practice (GMP) violations, particularly concerning the water system. The FDA criticized the system for its poor design, including stagnant water points, which can promote biofilm growth. The manufacturer's proposed improvements were deemed insufficient by the FDA, which expects:

- A comprehensive remediation plan for the water system's design, control, and maintenance.

- Elimination of stagnant points (dead legs) and necessary repairs.

- Validation of the water system.

- Establishment of a monitoring system with routine microbiological testing.

Additional issues included the lack of process validation. The FDA required:

- A detailed validation program covering the product lifecycle.

- A process performance qualification (PPQ) program and ongoing monitoring of batch variations.

- A schedule for conducting PPQs for all marketed products.

- Written procedures for equipment and facility qualification.

The FDA also found documentation and data integrity problems, noting unauthorized changes to GMP records and improper handling of raw laboratory data.The original Warning Letter is available on the FDA website.