FDA 483 - PLZ Corp - January 15, 2025

PLZ Corp in Fall River, MA, was cited for significant deficiencies in its manufacturing practices for drug products. The inspection revealed failures in establishing and following written procedures for equipment cleaning and maintenance, including a lack of cleaning validation and periodic verification for sunscreen and hand sanitizer production. Additionally, the firm failed to establish adequate written procedures for production and process controls, specifically regarding the validation of its sunscreen repackaging process.