PLZ Corp – FDA 483, Jan 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.
ID · 7209c4c7-7b3e-4562-8911-2b4e5d0c8d67
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.