FDA 483 - Zydus Lifesciences Limited - February 08, 2024

An FDA inspection conducted from February 5-8, 2024, at XPERIENCE SOAPS, LLC in Tampa, FL, identified significant deficiencies in the manufacturing of their Over-the-Counter (OTC) drug products, including hand sanitizers and body washes. This inspection revealed multiple repeat violations of Current Good Manufacturing Practice (CGMP) regulations, specifically 21 CFR Part 211.

Key issues included a complete absence of procedures to prevent microbiological contamination in non-sterile drug products, such as lacking water system monitoring and testing for both raw materials and finished products. The firm also failed to perform crucial finished product testing for the identity and strength of active ingredients (e.g., benzalkonium chloride, ethyl alcohol, salicylic acid) before distribution. Furthermore, XPERIENCE SOAPS, LLC lacked essential written production and process control procedures, including Master and Batch Production Records, with the owner reportedly relying on memory for manufacturing formulas. The company also failed to test incoming raw materials for identity, purity, strength, and quality, instead solely relying on supplier Certificates of Analysis without verification. Critically, no Quality Control Unit was established to oversee and approve materials, production, or finished product release, and there was no written program to assess drug product stability or justify assigned expiration dates. These observations require XPERIENCE SOAPS, LLC to implement comprehensive corrective actions to comply with federal regulations governing drug manufacturing.