FDA criticizes Water System at Korean Sunscreen Manufacturer

The FDA found numerous GMP violations during an inspection of a Korean manufacturer of an OTC sunscreen product. Among other things, the water system was objected.

According to the FDA, the water system - water is a component in the manufacturing process - is not adequately designed. For example, the water system has points of stagnant water (e.g., dead legs), including a point of use in the production area. Standing water is known to foster the development of biofilms, which is also noted by the FDA. Planned improvement measures by the manufacturer are not sufficient for the FDA as they do not sufficiently address the inadequate design of the water system. Among other things, the FDA expects:

• A comprehensive remediation plan for the design, control, and maintenance of the water system.
• Complete elimination of all repairs and necessary changes, such as the elimination of dead legs 
• Validation of the water system
• The establishment of a monitoring system including routine microbiological testing

Another finding is the lack of validation of the manufacturing process. In particular, the FDA lacks proof of the qualification of the manufacturing equipment. The FDA expects the following:

• A detailed summary of the validation program for ensuring a state of control throughout the product lifecycle and associated procedures
• A description of the program for process performance qualification (PPQ) and ongoing monitoring of intra-batch and inter-batch variation
• A schedule for conducting an appropriate PPQ for each of the marketed products
• Written procedures for the qualification of equipment and facilities

The FDA also found issues with documentation and data integrity.

According to the FDA, the quality unit failed to ensure adequate control of GMP records. As a result, employees can change GMP-relevant records without authorization, as employees can print out and discard these documents. An FDA inspector noticed original records (e.g. temperature and differential pressure monitoring checklists) in a container marked for shredding. Furthermore, laboratory employees stated that laboratory data (=raw data) is routinely recorded on preliminary logs and discarded after the data is later transferred to a final laboratory log.

The original Warning Letter can be found on the FDA website.