FDA Issues Warning Letter to Gussyup LLC for CGMP Violations in OTC Drug Manufacturing

On August 12, 2025, the U.S. Food and Drug Administration (FDA) published a Warning Letter, dated July 9, 2025, to Gussyup LLC dba Private Label Grooming, a U.S.-based manufacturer of over-the-counter (OTC) drug products. The letter followed a February 2025 inspection that revealed significant lapses in Current Good Manufacturing Practice (CGMP) compliance.

The FDA cited the company for failing to establish an effective Quality Unit (QU) with oversight authority, neglecting to test incoming raw materials for identity, purity, strength, and quality, and lacking a vendor qualification program for suppliers. Instead, the firm relied on unverified Certificates of Analysis (CoAs), without performing required identity testing or validating supplier data.

Given the history of poisoning incidents linked to diethylene glycol (DEG) and ethylene glycol (EG), the FDA emphasized the need for stringent, risk-based controls on excipients like glycerin and propylene glycol.

Although the company ceased OTC drug production, the Warning Letter was issued due to its failure to provide a corrective response. The full letter is available on the FDA website.

27-08-2025