FDA 483 - Pyramid Laboratories, Inc. - February 13, 2026

Pyramid Laboratories, Inc. in Costa Mesa, CA, received an FDA Form 483 with two observations during an inspection from February 2-13, 2026. The firm was cited for failing to ensure equipment surfaces contacting drug product were non-reactive, leading to recurrent impurity issues. Additionally, the inspection revealed a failure to thoroughly review unexplained discrepancies, including invalidating out-of-specification results without scientific justification and not initiating corrective actions for recurring quality control problems.