FDA EIR - Viarex Wholesale Inc. - November 29, 2016

Viarex Wholesale Inc., a distributor of dietary supplements and Chinese herbal products located in Oakland Garden, NY, underwent an FDA inspection on November 29, 2016. This limited inspection was conducted to verify the firm's operations and chain of distribution, falling under the regulatory framework of FDA guidelines 7321.008 (Dietary Supplements-Import) and 7303.803 (Domestic Food Safety Inspections).

The inspection revealed that Viarex Wholesale Inc. operates as a single-person proprietorship by Mr. Kok Yat Wong from a leased basement in a residential building. The firm functions solely as a distributor, purchasing products from US wholesalers and selling them online; it performs no manufacturing, repacking, or relabeling activities at this location. While a previous inspection in 2008 identified a significant issue involving a dietary supplement found to contain tadalafil, an unapproved drug, the current inspection reported "no inspectional observations." This means no significant violations or issues were identified, and therefore, no FDA-483 form (detailing regulatory observations) was issued. Labels for reviewed products appeared compliant.

Consequently, no specific regulatory actions were required from the company as a result of this inspection. The owner was provided with information regarding FDA fees and an Alert card.