FDA 483 - Naturich Cosmetique Labs - May 02, 2025
Discuss this record with AI
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.
Naturich Cosmetique Labs in Garland, TX, a contract manufacturer of OTC drugs, received a Form 483 with six observations during an inspection from 4/28/2025 to 5/2/2025. The inspection revealed significant deficiencies in process validation, investigation of out-of-specification results and microbial contamination in the water system, raw material testing, batch record documentation, annual product review procedures, and cleaning validation. Several observations were repeats from previous inspections, indicating persistent issues with quality control and manufacturing processes.
- Office
- Dallas District Office
- Person
ID · 7cde77c4-1c6c-4858-8842-c0132b1010c9