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Talk to a SpecialistTalk to a SpecialistNaturich Cosmetique Labs, a manufacturer of over-the-counter topical drug products for infants, violated Current Good Manufacturing Practice (CGMP) regulations by failing to establish adequate written procedures for production and process control. The company's water system—a critical component in manufacturing—was not properly validated, maintained, sanitized, or monitored to ensure it consistently met appropriate chemical and microbial quality standards, rendering the drug products adulterated. The FDA found the company's May 2025 response to inspection findings inadequate because it failed to provide supporting documentation or sufficient evidence of corrective actions needed to achieve compliance.