FDA 483 - C&T Dream Co., Ltd. - November 10, 2023

This FDA Form 483 details nine observations from an inspection. The facility manufactures and distributes OTC drug product "Walgreens, Dry Skin Healing Ointment," specifically lot number WDT23108, which was distributed to the US market.

Key violations include: 1. **Deficient Laboratory Records:** The firm could not provide data supporting microbiological testing for a system used in cleaning Tank 05 prior to manufacturing the ointment. 2. **Inadequate Process Control Procedures:** Control procedures are not established to monitor and validate manufacturing processes causing variability. 3. **Insufficient Stability Studies:** No long-term stability studies were conducted for the OTC drug product. An R&D study from May 2022 was used to establish the expiration date for lot WDT23108 without verification by actual shelf-life studies. 4. **Inadequate Environmental Controls:** Buildings used for manufacturing, packaging, and warehousing lack mechanical systems for controlling temperature, humidity, and differential pressure, despite being classified as ISO 7 and ISO 8 equivalents. 5. **Poor Building Maintenance:** Extensive water damage, apparent mold at the building entrance leading to production, and plastic sheets collecting roof leaks were observed in the building where the ointment was filled. 6. **Unqualified Component Suppliers:** The firm has not qualified raw material suppliers for the ointment by evaluating Certificates of Analysis via analytical testing, relying only on appearance, color