FDA WARNING_LETTER - Gussyup LLC dba Private Label Grooming - February 20, 2025

The FDA issued a warning letter to Gussyup LLC, operating as Private Label Grooming, following an inspection of their Henderson, NV facility from February 18 to 20, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, as outlined in 21 CFR parts 210 and 211. Key issues included the failure of the firm"s quality control unit to ensure compliance with CGMP standards, inadequate quality systems, and the absence of a vendor qualification program. The firm also failed to conduct necessary identity tests on incoming drug components, relying instead on unverified supplier certificates of analysis, which poses risks of contamination with harmful substances like diethylene glycol or ethylene glycol.

The FDA has not received a response from Gussyup LLC regarding corrective actions for these deficiencies. The company has indicated its intention to cease production of over-the-counter drugs and has discontinued its FDA drug registration. However, the FDA requires clarification on whether the firm plans to resume drug manufacturing in the future. If so, Gussyup LLC must notify the FDA and demonstrate compliance with CGMP standards before resuming operations.

The FDA recommends that Gussyup LLC engage a qualified CGMP consultant to conduct a comprehensive audit and assist in addressing the violations. The firm must respond in writing within 15 working days, detailing corrective actions taken and plans to prevent recurrence. Failure to adequately address these issues may result in regulatory actions, including seizure, injunction, or withholding of approvals and contracts.