According to the administration, investigators witnessed insanitary conditions while conducting an inspection on the Ohio based facility in October, November and December.
On its website, the FDA says inspection of several insanitary practices were observed that have the potential to cause the company’s product to be contaminated with filth or become injurious to health.
It then points to the company’s Triple Lanolin Aloe Vera Foot Scrub; “An analysis of your Triple Lanolin Aloe Vera Foot Scrub collected during the inspection found significant microbial contamination. It is therefore a violation of Section 301(a) of the Act [21 USC 331(a)] to introduce or deliver for introduction into interstate commerce any cosmetic that is adulterated or misbranded.”
The administration also highlights that there was 'apparent filth and dust build up on the manufacturing equipment in the production area and a layer of sediment and encrusted material was observed on the exterior and tops of production kettles in use.'
After outlining the complaint, the FDA goes on to acknowledge Vienna Beauty Product's receipt of response way back in November, however, it ruled it inadequate as the company did not provide any detailed information regarding proposed corrective actions that it planned to take.
"You are responsible for investigating and determining the causes of the violation identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility as a manufacturer to ensure that the products your firm markets are safe and otherwise in compliance with all applicable legal and regulatory requirements."
Finally, the letter advises the company's CEO "to take prompt action to correct the violations”, regardless of its initial response.
Failure to implement lasting corrective action of violations may result in regulatory action being initiated by the FDA without further notice.
Cosmetics Design approached representatives from Vienna Beauty Products and the FDA for an update on the issue, but found they were unavailable for comment at the time of publication.