The US Food and Drug Administration (FDA) issued a Warning Letter to Accra Pac (dba Voyant Beauty) after inspecting its manufacturing facility in Elkhart, IN. According to FDA, the products tested contained unacceptable levels of benzene. FDA said the finding “demonstrates that the quality assurance within your facility is not functioning in accordance with CGMP requirements.”

Specifically, FDA charged:

1. The company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

2. The company failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).

3. The company failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).

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