FDA Issues Warning to OTC Manufacturer Over Serious GMP Violations

In March 2025, the FDA issued a warning letter to Libby Laboratories, Inc., a U.S. manufacturer of OTC products, citing major GMP violations. Inspectors found the company used grocery store water in production and released disinfectant batches—including one for a children’s hospital—without microbiological testing, relying instead on the product’s claimed bactericidal properties.

The FDA deemed this justification scientifically unsubstantiated, demanding complete chemical and microbiological specifications, testing methods, and retained sample testing.

The firm also failed to independently verify raw material identity, relying solely on supplier CoAs, and lacked qualified supplier systems and proper incoming inspections.

The FDA now requires a full material system review, updated testing protocols, and a risk assessment for potentially affected products still on the market. A qualified GMP consultant is recommended to overhaul the deficient quality system and restore regulatory compliance.

The full letter is available on the FDA website.

30-07-2025