FDA 483 - CBI Laboratories, Inc. dba Voyant Beauty LLC. - May 14, 2019

CTL Laboratories, Inc. in Fort Worth, TX, a contract manufacturer of OTC human topical drug products, received a Form 483 with six observations during an inspection from May 6-14, 2019. The inspection revealed significant deficiencies across multiple systems, including inadequate quality control unit procedures, lack of annual product reviews, absence of written production and process controls (a repeat observation), insufficient cleaning validation, poorly designed equipment for cleaning, and inadequate material segregation. These issues indicate a systemic failure to adhere to Good Manufacturing Practices, posing a risk to product quality and purity.