Formology Lab Gets Warning Letter for Lax Identity Testing, Other Lapses

Formology Lab of Chatsworth, Calif., earned an FDA warning letter for failing to verify the identity of each component of a drug product, having no written procedures for process or production control, among other serious lapses.

The warning letter explains that the drugmaker failed to test active pharmaceutical ingredients before using them to manufacture its over-the-counter drug products, noting that product batches had been released before the company completed identity testing.

Other issues noted in the FDA warning letter included a lack of data to demonstrate that the water used for manufacturing met standards for pharmaceutical use.

The problems were identified during an August to September 2022 inspection, and while FDA acknowledged the firm’s response to the initial Form 483, the agency said the replies lacked details about how corrective action plans will be effectively implemented.