The US Food and Drug Administration (FDA) issued a Warning Letter to Naturich Cosmetique Labs, Garland, TX. FDA found violations of Current Good Manufacturing Practice regulations for finished pharmaceuticals. Specifically, FDA said:

Naturich failed to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality and purity they purport or are represented to possess (21 CFR 211.100(a)).

FDA noted Naturich uses water as a component to manufacture topical over-the-counter (OTC) drug products including skin protectants applied to irritated and potentially broken skin of infants. FDA said the company failed to adequately validate its water production process to ensure the system was consistently producing water of appropriate quality for its intended use. Additionally, FDA said the water system was not adequately maintained nor periodically sanitized. Furthermore, Naturich failed to demonstrate its water system was adequately monitored to ensure it consistently produced water that met appropriate chemical and microbial quality standards.

FDA said Naturich failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Specifically, FDA said Naturich failed to adequately investigate multiple microbiological out-of-limit (OOL) results from the water system used to manufacture topical drug products.

Naturich failed to conduct at least one test to verify the identity of each component of a drug product. The company also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)), according to FDA. Naturich manufactures OTC topical drug products, including but not limited to hand sanitizer and skin protectants. 

FDA recommended hiring a consultant qualified as set forth in 21 CFR 211.34 to evaluate operations and to assist in meeting CGMP requirements.