Letter From Quality Control

Our Commitment To Safety, Testing And Compliance!

We only have to look to recent headlines to discover products that were sold as safe caused illness, and in some cases, death, because of contamination.

Aside from microbiological contamination, there can be questions of product purity and the reliability of the ingredient label claim.

We take the mission of providing a safe product seriously by undergoing regular audits by the Food and Drug Administration (FDA) and numerous third parties. We manufacture cosmetics and Over-the-Counter (OTC) drug products for customers all over the world including, most major retailers, private label, contract manufacturing and for the promotional products industry. OraLabs, Inc. applies the same high standards for all customers.

OraLabs, Inc. is registered as a Drug Establishment on the FDA’s website. To view our current year registration, go to
www.accessdata.fda.gov/scripts/cder/drls/default.cfm, type OraLabs in the space and click the Submit Query button. Registered facilities are regularly audited by the FDA. Always know if the products you buy come from a registered facility.

OraLabs, Inc. has systems which meet the FDA’s current Good Manufacturing Practices listed in 21 Code of Federal Regulations, parts 210 and 211. These are federally mandated regulations passed by Congress that list requirements for Over-the-Counter drugs.

OraLabs, Inc. uses ingredients that meet or exceed the requirements defined in the United States Pharmacopeia (USP) for cosmetic and OTC drug use. We perform analytical and microbiological testing on every batch to ensure compliance.

OraLabs, Inc. reviews labeling regulations and develops artwork templates to be compliant.

For questions regarding our manufacturing processes or other technical issues, contact me directly.

Sincerely,
Teresa Purdue
Quality Assurance Director
Phone (303) 783-9499, Ext. 3249
Fax (303) 783-5759
[email protected]

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