FDA EIR - Wasatch Product Development, LLC - April 09, 2019

An FDA surveillance inspection of Wasatch Product Development, LLC, a contract manufacturer of dietary supplements, cosmetics, and over-the-counter drugs, was conducted from April 3 to April 9, 2019. The inspection, performed under Compliance Program 7321.008 for Dietary Supplements, revealed significant issues outlined in an FDA-483 form. The primary violations concerned the firm's quality control operations, referencing 21 CFR 111.103. Specifically, the company lacked established and followed written procedures for: 1) a valid testing method for the identity of melatonin as a raw material; 2) a valid testing method for the strength of melatonin in finished products; and 3) finished product specifications for the strength of calcium and magnesium. Furthermore, Wasatch did not create a Master Manufacturing Record (MMR) for each unique batch size of dietary supplements produced, instead adapting a single MMR for various sizes. A verbally discussed item also noted that the firm did not consistently list testing methods on Certificates of Analysis (COAs). Management, including the Vice President of Quality/Regulatory, acknowledged the observations and pledged full compliance. The company initiated immediate corrective actions, including temporarily ceasing dietary supplement manufacturing. They began addressing issues by purchasing melatonin identity standards, sending samples to a third-party lab for testing, updating raw material and finished product specifications, and committing to create unique MMRs for each batch size. A detailed written response outlining all corrective actions was promised within 15 days, with legal sanctions like seizure or injunction explained as potential FDA actions if not addressed.