FDA Warning Letter Highlights Major Lab Control Failures at OTC Manufacturer

The U.S. Food and Drug Administration has issued a warning letter to Pro Numb Tattoo Numbing Spray LLC following an inspection of its Palm Bay, Florida facility, citing serious current good manufacturing practice (CGMP) violations with a strong focus on laboratory controls.

A key concern was the absence of finished-product testing, with batches released without verifying identity, strength, or quality attributes. The company’s proposal to rely on a contract laboratory lacked sufficient detail and did not include plans for retrospective testing of products already distributed.

The FDA also flagged deficiencies in raw material controls, including missing identity testing and overreliance on supplier certificates of analysis without proper validation. Additional issues included an inadequate stability program and data integrity lapses, with poor documentation practices undermining test reliability.

Further findings pointed to unvalidated manufacturing processes and the absence of a functional quality unit to oversee operations. The agency also classified the products as unapproved and misbranded, noting the firm’s commitment to a voluntary recall of affected batches.

04-05-2026