18685 E. Plaza Drive Parker, CO 80134

Quality Compliance

The Quality Assurance team monitors our strict cGMP production and processes through internal audits to assure a strict regulatory compliant environment. All processes are managed through Standard Operating Procedures. Validation work and testing methods are compliant under CFR 21 regulations. Our in house Micro Lab tests every batch prior to leaving our facility. In addition to the FDA, OraLabs has many outside audits performed to comply with customer requirements.





OraLabs, Inc. (OraLabs) is a manufacturer, distributor, and marketer of cosmetic, OTC and medical device products. The Company’s success is attributed to the innovative product line, experienced employees, quality orientation, and customer service. Our customers rightly expect the very best from OraLabs. At OraLabs, the staff and management are committed to consistently providing quality products and services that satisfy customer’s and regulatory expectations. OraLabs is a dynamic organization thriving on change and committed to continual improvement and achieving zero defects in all areas through application of Pharmaceutical Current Good Manufacturing Practices (CGMP). Employees of OraLabs hold each other and themselves accountable for CGMP in all aspects of product and service delivery to ensure employees are invested in the process. Employees are encouraged to communicate quality deficiencies to management to ensure quick and efficient corrections so that quality products and services may always be delivered to the customer.
OraLabs complies with US FDA regulatory requirements for cosmetic, OTC and medical device products as applicable to the products manufactured to satisfy all external regulatory and internal compliance requirements. These requirements are communicated to customers and employees to ensure product and service quality is met.