Private Label Grooming Gets an FDA Warning Letter

The US Food and Drug Administration issued a Warning Letter to GussyUp LLC dba Private Label Grooming, a Nevada LLC. The Warning Letter summarized “significant violations” of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. Private Label Grooming provides progressive barbers and salons the opportunity to offer clients their own exclusive range.

According to the FDA, the firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

The FDA found Private Label Grooming failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

FDA acknowledged the company’s commitment to cease production of all OTC drugs at this facility. The FDA requested clarity on whether Private Label Grooming intended to resume manufacturing any drugs at this facility in the future.

Earlier this month, FDA issued a Warning Letter to Vacation Classic Whipped Sunscreen.